xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05991453</url>
    </required_header>
    <id_info>
      <org_study_id>202304082</org_study_id>
      <nct_id>NCT05991453</nct_id>
    </id_info>
    <brief_title>Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial</brief_title>
    <acronym>THRIVE</acronym>
    <official_title>Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Washington University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Patient-Centered Outcomes Research Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Michigan</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Washington University School of Medicine</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The investigators will conduct a 12,500-patient randomized multi-center trial to determine&#xD;
        (i) which general anesthesia technique yields superior patient recovery experiences in any of&#xD;
        three surgical categories ((a) major inpatient surgery, (b) minor inpatient surgery, (c)&#xD;
        outpatient surgery) and (ii) whether TIVA confers no more than a small (0.2 %) increased risk&#xD;
        of intraoperative awareness than INVA in patients undergoing both outpatient and inpatient&#xD;
        surgeries&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2028</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Quality of Recovery-15 (QOR 15) score on POD1 after Major inpatient surgery</measure>
      <time_frame>baseline to day 1</time_frame>
      <description>We will compare the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD1 and assess the difference between scores. A large difference between the baseline and POD1 score may indicate significant impact on quality of recovery after surgery type.&#xD;
  Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of Recovery-15 score on POD1 after minor inpatient surgery</measure>
      <time_frame>baseline to day 1</time_frame>
      <description>We will compare the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) minor inpatient surgery. taken by the participant at baseline and then again at POD1 and assess the difference between scores. A large difference between the baseline and POD1 score may indicate significant impact on quality of recovery after surgery type.&#xD;
  Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of Recovery-15 score on POD1 after Outpatient surgery</measure>
      <time_frame>baseline to day 1</time_frame>
      <description>We will compare the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) outpatient surgery. taken by the participant at baseline and then again at POD1 and assess the difference between scores. A large difference between the baseline and POD1 score may indicate significant impact on quality of recovery after surgery type.&#xD;
  Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of unintended intraoperative awareness with recall on POD1 or POD30</measure>
      <time_frame>30 days</time_frame>
      <description>Determine whether the incidence of intraoperative awareness with TIVA is non-inferior to that with INVA. Otherwise stated, to determine whether TIVA confers no more than a small (0.2%) increased risk of intraoperative awareness than INVA.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Quality of Recovery-15 score on POD0 after major inpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD0 and assess the difference between scores. A large difference between the baseline and POD0 score may indicate significant impact on quality of recovery after surgery type.&#xD;
  Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Recovery-15 score on POD0 minor inpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) minor inpatient surgery. taken by the participant at baseline and then again at POD0 and assess the difference between scores. A large difference between the baseline and POD0 score may indicate significant impact on quality of recovery after surgery type.&#xD;
  Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Recovery-15 score on POD0 outpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) out[atient surgery. taken by the participant at baseline and then again at POD0 and assess the difference between scores. A large difference between the baseline and POD0 score may indicate significant impact on quality of recovery after surgery type.&#xD;
  Difference in baseline versus POD# (POD0, POD1, POD7) will be compared and assessed over the participants time in the study to measure the rate the participant returns to baseline QOR score.&#xD;
  Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Recovery-15 score on POD2 after major inpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD2 and assess the difference between scores. A large difference between the baseline and POD2 score may indicate significant impact on quality of recovery after surgery type.&#xD;
  Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Recovery-15 score on POD2 after minor inpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a)minor inpatient surgery. taken by the participant at baseline and then again at POD2 and assess the difference between scores. A large difference between the baseline and POD2 score may indicate significant impact on quality of recovery after surgery type.&#xD;
  Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Recovery-15 score on POD2 after outpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) outpatient surgery. taken by the participant at baseline and then again at POD2 and assess the difference between scores. A large difference between the baseline and POD2 score may indicate significant impact on quality of recovery after surgery type.&#xD;
  Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Recovery-15 score on POD7 after major inpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD7 and assess the difference between scores. A large difference between the baseline and POD7 score may indicate significant impact on quality of recovery after surgery type.&#xD;
  Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Recovery-15 score on POD7 after minor inpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) minor inpatient surgery. taken by the participant at baseline and then again at POD7 and assess the difference between scores. A large difference between the baseline and POD7 score may indicate significant impact on quality of recovery after surgery type.&#xD;
  Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Recovery-15 score on POD7 after outpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) out[aitnet surgery. taken by the participant at baseline and then again at POD7 and assess the difference between scores. A large difference between the baseline and POD7 score may indicate significant impact on quality of recovery after surgery type.&#xD;
  Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of delirium on POD0 after major inpatient surgery</measure>
      <time_frame>1 day</time_frame>
      <description>Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing major inpatient surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of delirium on POD0 after minor surgery</measure>
      <time_frame>1 day</time_frame>
      <description>Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing minor inpatient surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of delirium on POD1 after major inpatient</measure>
      <time_frame>1 day</time_frame>
      <description>Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing outpatient surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of delirium on POD1 after minor inpatient surgery</measure>
      <time_frame>1 day</time_frame>
      <description>Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing major inpatient surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of delirium on POD1 after outpatient surgery</measure>
      <time_frame>1 day</time_frame>
      <description>Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing outpatient surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Patient Health Questionnaire 4 (PHQ 4) on POD7 after major inpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>The changes in anxiety and depression The PHQ - 4 is a screening test. A positive screen on each screening subscale causes the participant to be delivered the relevant full questionnaire of the PHQ 8.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Patient Health Questionnaire 4 (PHQ 4) at baseline for those having major inpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>The changes in anxiety and depression The PHQ - 4 is a screening test. A positive screen on each screening subscale causes the participant to be delivered the relevant full questionnaire of the PHQ 8.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Patient Health Questionnaire 4 (PHQ 4) on POD7 after minor inpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>The changes in anxiety and depression&#xD;
  The PHQ - 4 is a screening test. A positive screen on each screening subscale causes the participant to be delivered the relevant full questionnaire of the PHQ 8.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Patient Health Questionnaire 4 (PHQ 4) at baseline for those having minor inpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>The changes in anxiety and depression&#xD;
  The PHQ - 4 is a screening test. A positive screen on each screening subscale causes the participant to be delivered the relevant full questionnaire of the PHQ 8.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Patient Health Questionnaire 4 (PHQ 4) on POD7 after outpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>The changes in anxiety and depression&#xD;
  The PHQ - 4 is a screening test. A positive screen on each screening subscale causes the participant to be delivered the relevant full questionnaire of the PHQ 8.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Patient Health Questionnaire 4 (PHQ 4) at baseline for those having outpatient surgery.</measure>
      <time_frame>7 days</time_frame>
      <description>The changes in anxiety and depression&#xD;
  The PHQ - 4 is a screening test. A positive screen on each screening subscale causes the participant to be delivered the relevant full questionnaire of the PHQ 8.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Patient Health Questionnaire 8 (PHQ 8) on POD7 after minor inpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>The changes in anxiety and depression&#xD;
  The PHQ-8: Score is the sum of the 8 items. A higher score indicates the possible presence of depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Patient Health Questionnaire 8 (PHQ 8) at baseline for those having minor inpatient surgery..</measure>
      <time_frame>7 days</time_frame>
      <description>The changes in anxiety and depression&#xD;
  The PHQ-8: Score is the sum of the 8 items. A higher score indicates the possible presence of depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Patient Health Questionnaire 8 (PHQ 8) on POD7 after major inpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>The changes in anxiety and depression&#xD;
  The PHQ-8: Score is the sum of the 8 items. A higher score indicates the possible presence of depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Patient Health Questionnaire 8 (PHQ 8) at baseline for those having major inpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>The changes in anxiety and depression&#xD;
  The PHQ-8: Score is the sum of the 8 items. A higher score indicates the possible presence of depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Patient Health Questionnaire 8 (PHQ 8) on POD7 after outpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>The changes in anxiety and depression&#xD;
  The PHQ-8: Score is the sum of the 8 items. A higher score indicates the possible presence of depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Patient Health Questionnaire 8 (PHQ 8) at baseline for those having outpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>The changes in anxiety and depression&#xD;
  The PHQ-8: Score is the sum of the 8 items. A higher score indicates the possible presence of depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalized Anxiety Disorder - 7 (GAD 7) on POD7 after minor inpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>Generalized Anxiety Disorder - 7 (GAD 7) Scoring: Score is the sum of the 7 items. Higher scores indicate the presence of anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalized Anxiety Disorder - 7 (GAD 7) at baseline for those having minor inpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>Generalized Anxiety Disorder - 7 (GAD 7) Scoring: Score is the sum of the 7 items. Higher scores indicate the presence of anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalized Anxiety Disorder - 7 (GAD 7) on POD7 after major inpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>Generalized Anxiety Disorder - 7 (GAD 7) Scoring: Score is the sum of the 7 items. Higher scores indicate the presence of anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalized Anxiety Disorder - 7 (GAD 7) at baseline for those having major inpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>Generalized Anxiety Disorder - 7 (GAD 7) Scoring: Score is the sum of the 7 items. Higher scores indicate the presence of anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalized Anxiety Disorder - 7 (GAD 7) on POD7 after outpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>Generalized Anxiety Disorder - 7 (GAD 7) Scoring: Score is the sum of the 7 items. Higher scores indicate the presence of anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalized Anxiety Disorder - 7 (GAD 7) at baseline for those having outpatient surgery</measure>
      <time_frame>7 days</time_frame>
      <description>Generalized Anxiety Disorder - 7 (GAD 7) Scoring: Score is the sum of the 7 items. Higher scores indicate the presence of anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Days alive and at-home at POD30 after major inpatient surgery</measure>
      <time_frame>30 days</time_frame>
      <description>The patient will be asked if they were re-admitted to the hospital after the index surgery. If yes, the numbers of days in the hospital will be recorded.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Days alive and at-home at POD30 after minor inpatient surgery</measure>
      <time_frame>30 days</time_frame>
      <description>The patient will be asked if they were re-admitted to the hospital after the index surgery. If yes, the numbers of days in the hospital will be recorded.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ-5D-5L Quality of life on POD30 after major inpatient surgery</measure>
      <time_frame>30 days</time_frame>
      <description>EQ-5D-5L Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.&#xD;
  EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ-5D-5L Quality of life on POD30 after minor inpatient surgery</measure>
      <time_frame>30 days</time_frame>
      <description>Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.&#xD;
  EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ-5D-5L Quality of life on POD30 after outpatient surgery</measure>
      <time_frame>30 days</time_frame>
      <description>Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.&#xD;
  EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ-5D-5L Quality of life on POD90 after major inpatient surgery</measure>
      <time_frame>90 days</time_frame>
      <description>Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.&#xD;
  EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ-5D-5L Quality of life on POD90 after minor inpatient surgery</measure>
      <time_frame>90 days</time_frame>
      <description>Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.&#xD;
  EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ-5D-5L Quality of life on POD90 after outpatient surgery</measure>
      <time_frame>90 days</time_frame>
      <description>Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.&#xD;
  EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ-5D-5L Quality of life on POD180 after major inpatient surgery</measure>
      <time_frame>180 days</time_frame>
      <description>Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.&#xD;
  EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ-5D-5L Quality of life on POD180 after minor inpatient surgery</measure>
      <time_frame>180 days</time_frame>
      <description>Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.&#xD;
  EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ-5D-5L Quality of life on POD180 after outpatient surgery</measure>
      <time_frame>180 days</time_frame>
      <description>Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.&#xD;
  EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ-5D-5L Quality of life on POD365 after major inpatient surgery</measure>
      <time_frame>365 days</time_frame>
      <description>Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.&#xD;
  EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ - 5D-5L Quality of life on POD365 after minor inpatient surgery</measure>
      <time_frame>365 days</time_frame>
      <description>Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.&#xD;
  EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ-5D-5L Quality of life on POD365 after out patient surgery</measure>
      <time_frame>365 days</time_frame>
      <description>Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.&#xD;
  EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bauer Questionnaire - Patient satisfaction with anesthesia at POD2</measure>
      <time_frame>2 days</time_frame>
      <description>Bauer questionnaire - Self-report satisfaction survey focused on satisfaction with anesthesia. Satisfaction is measured by reporting an experience as happening and if it did was it moderate or severe. As well as satisfaction for each aspect of anesthesia care:&#xD;
  &quot;very satisfied&quot;, &quot;satisfied&quot;, &quot;dissatisfied&quot;, or &quot;very dissatisfied&quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory failure on POD0</measure>
      <time_frame>1 day</time_frame>
      <description>Respiratory failure on POD0</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>kidney injury on POD7</measure>
      <time_frame>7 days</time_frame>
      <description>kidney injury on POD7</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>all-cause mortality at POD30</measure>
      <time_frame>30 days</time_frame>
      <description>all-cause mortality at POD30</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>all-cause mortality at POD90</measure>
      <time_frame>90 days</time_frame>
      <description>all-cause mortality at POD90</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>intraoperative hypotension</measure>
      <time_frame>90 days</time_frame>
      <description>intraoperative hypotension</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>moderate to severe intraoperative patient movement</measure>
      <time_frame>90 days</time_frame>
      <description>moderate to severe intraoperative patient movement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>unplanned admission after outpatient surgery in an ambulatory setting</measure>
      <time_frame>90 days</time_frame>
      <description>unplanned admission after outpatient surgery in an ambulatory setting</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of propofol-related infusion syndrome, and malignant hyperthermia as reported in the EHR</measure>
      <time_frame>90 days</time_frame>
      <description>Incidence of propofol-related infusion syndrome, and malignant hyperthermia as reported in the EHR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of malignant hyperthermia as reported in the EHR</measure>
      <time_frame>90 days</time_frame>
      <description>Incidence of malignant hyperthermia as reported in the EHR</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Daily step count as measured by wearable device at baseline for those scheduled for major inpatient surgery.</measure>
      <time_frame>1 - 7 days prior to surgery</time_frame>
      <description>Daily step count at baseline - number of steps per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Daily step count as measured by wearable device at baseline for those scheduled for minor inpatient surgery.</measure>
      <time_frame>1 - 7 days prior to surgery</time_frame>
      <description>Daily step count at baseline - number of steps per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Daily step count as measured by wearable device at baseline for those scheduled for outpatient surgery.</measure>
      <time_frame>1 - 7 days prior to surgery</time_frame>
      <description>Daily step count at baseline - number of steps per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Daily step count as measured by wearable device for those scheduled for outpatient surgery.</measure>
      <time_frame>7 - 10 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Daily step count as measured by wearable device for those scheduled for major inpatient surgery.</measure>
      <time_frame>7 - 10 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Daily step count as measured by wearable device for those scheduled for minor inpatient surgery.</measure>
      <time_frame>7 - 10 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Daily step count as measured by wearable device for those scheduled for minor inpatient surgery.</measure>
      <time_frame>30 - 34 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Daily step count as measured by wearable device for those scheduled for major inpatient surgery.</measure>
      <time_frame>30 - 34 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Daily step count as measured by wearable device for those scheduled for outpatient surgery.</measure>
      <time_frame>30 - 34 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Daily standing hours as measured by wearable device at baseline for those scheduled for major inpatient surgery.</measure>
      <time_frame>1 - 7 days prior to surgery</time_frame>
      <description>Daily standing hours: defined as standing hours per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Daily standing hours as measured by wearable device at baseline for those scheduled for minor inpatient surgery.</measure>
      <time_frame>1 - 7 days prior to surgery</time_frame>
      <description>Daily standing hours: defined as standing hours per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Daily standing hours as measured by wearable device at baseline for those scheduled for outpatient surgery.</measure>
      <time_frame>1 - 7 days prior to surgery</time_frame>
      <description>Daily standing hours: defined as standing hours per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Daily standing hours as measured by wearable device for those scheduled for outpatient surgery.</measure>
      <time_frame>7 - 10 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device.&#xD;
  Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Daily standing hours as measured by wearable device for those scheduled for major inpatient surgery.</measure>
      <time_frame>7 - 10 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device.&#xD;
  Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Daily standing hours as measured by wearable device for those scheduled for minor inpatient surgery.</measure>
      <time_frame>7 - 10 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device.&#xD;
  Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Daily standing hours as measured by wearable device for those scheduled for minor inpatient surgery.</measure>
      <time_frame>30 - 34 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device.&#xD;
  Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Daily standing hours as measured by wearable device for those scheduled for major inpatient surgery.</measure>
      <time_frame>30 - 34 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device.&#xD;
  Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Daily standing hours as measured by wearable device for those scheduled for outpatient surgery.</measure>
      <time_frame>30 - 34 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device.&#xD;
  Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Total sleep time as measured at baseline by wearable device for those scheduled for outpatient surgery.</measure>
      <time_frame>1 - 7 days prior to surgery</time_frame>
      <description>Total sleep time defined as minutes of total sleep time per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Total sleep time as measured at baseline by wearable device for those scheduled for major inpatient surgery.</measure>
      <time_frame>1 - 7 days prior to surgery</time_frame>
      <description>Total sleep time defined as minutes of total sleep time per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Total sleep time as measured at baseline by wearable device for those scheduled for minor inpatient surgery.</measure>
      <time_frame>1 - 7 days prior to surgery</time_frame>
      <description>Total sleep time defined as minutes of total sleep time per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Total sleep time as measured by wearable device for those scheduled for minor inpatient surgery.</measure>
      <time_frame>7 - 10 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device&#xD;
  Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Total sleep time as measured by wearable device for those scheduled for major inpatient surgery.</measure>
      <time_frame>7 - 10 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device&#xD;
  Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Total sleep time as measured by wearable device for those scheduled for outpatient surgery.</measure>
      <time_frame>7 - 10 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device&#xD;
  Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Total sleep time as measured by wearable device for those scheduled for outpatient surgery.</measure>
      <time_frame>30 - 34 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device&#xD;
  Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Total sleep time as measured by wearable device for those scheduled for major inpatient surgery.</measure>
      <time_frame>30 - 34 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device&#xD;
  Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Total sleep time as measured by wearable device for those scheduled for minor inpatient surgery.</measure>
      <time_frame>30 - 34 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device&#xD;
  Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Sleep onset latency as measured by wearable device at baseline for those scheduled for minor inpatient surgery.</measure>
      <time_frame>1 - 7 days prior to surgery</time_frame>
      <description>Sleep onset latency: defined as minutes of sleep onset latency per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Sleep onset latency as measured by wearable device at baseline for those scheduled for major inpatient surgery.</measure>
      <time_frame>1 - 7 days prior to surgery</time_frame>
      <description>Sleep onset latency: defined as minutes of sleep onset latency per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Sleep onset latency as measured by wearable device at baseline for those scheduled for outpatient surgery.</measure>
      <time_frame>1 - 7 days prior to surgery</time_frame>
      <description>Sleep onset latency: defined as minutes of sleep onset latency per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Sleep onset latency as measured by wearable device for those scheduled for outpatient surgery.</measure>
      <time_frame>7 - 10 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device&#xD;
  Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Sleep onset latency as measured by wearable device for those scheduled for minor inpatient surgery.</measure>
      <time_frame>7 - 10 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device&#xD;
  Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Sleep onset latency as measured by wearable device for those scheduled for major inpatient surgery.</measure>
      <time_frame>7 - 10 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device&#xD;
  Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Sleep onset latency as measured by wearable device for those scheduled for major inpatient surgery.</measure>
      <time_frame>30 - 34 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device&#xD;
  Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Sleep onset latency as measured by wearable device for those scheduled for minor inpatient surgery.</measure>
      <time_frame>30 - 34 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device&#xD;
  Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Sleep onset latency as measured by wearable device for those scheduled for outpatient surgery.</measure>
      <time_frame>30 - 34 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device&#xD;
  Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day</description>
    </other_outcome>
    <other_outcome>
      <measure>Wake after sleep onset as measured by wearable device for those scheduled for outpatient surgery.</measure>
      <time_frame>1 - 7 days prior to surgery</time_frame>
      <description>Wake after sleep onset: defined as minutes of wake after sleep onset</description>
    </other_outcome>
    <other_outcome>
      <measure>Wake after sleep onset as measured by wearable device for those scheduled for major inpatient surgery.</measure>
      <time_frame>1 - 7 days prior to surgery</time_frame>
      <description>Wake after sleep onset: defined as minutes of wake after sleep onset</description>
    </other_outcome>
    <other_outcome>
      <measure>Wake after sleep onset as measured by wearable device for those scheduled for minor inpatient surgery.</measure>
      <time_frame>1 - 7 days prior to surgery</time_frame>
      <description>Wake after sleep onset: defined as minutes of wake after sleep onset</description>
    </other_outcome>
    <other_outcome>
      <measure>Wake after sleep onset as measured by wearable device for those scheduled for minor inpatient surgery.</measure>
      <time_frame>7 - 10 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device&#xD;
  Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset</description>
    </other_outcome>
    <other_outcome>
      <measure>Wake after sleep onset as measured by wearable device for those scheduled for major inpatient surgery.</measure>
      <time_frame>7 - 10 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device&#xD;
  Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset</description>
    </other_outcome>
    <other_outcome>
      <measure>Wake after sleep onset as measured by wearable device for those scheduled for outpatient surgery.</measure>
      <time_frame>7 - 10 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device&#xD;
  Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset</description>
    </other_outcome>
    <other_outcome>
      <measure>Wake after sleep onset as measured by wearable device for those scheduled for outpatient surgery.</measure>
      <time_frame>30 - 34 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device&#xD;
  Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset</description>
    </other_outcome>
    <other_outcome>
      <measure>Wake after sleep onset as measured by wearable device for those scheduled for minor inpatient surgery.</measure>
      <time_frame>30 - 34 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device&#xD;
  Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset</description>
    </other_outcome>
    <other_outcome>
      <measure>Wake after sleep onset as measured by wearable device for those scheduled for major inpatient surgery.</measure>
      <time_frame>30 - 34 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device&#xD;
  Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset</description>
    </other_outcome>
    <other_outcome>
      <measure>Sleep efficiency as measured at baseline by wearable device for those scheduled for major inpatient surgery.</measure>
      <time_frame>1 - 7 days prior to surgery</time_frame>
      <description>Sleep efficiency: defined as % sleep efficiency (ranging from 0-100)</description>
    </other_outcome>
    <other_outcome>
      <measure>Sleep efficiency as measured at baseline by wearable device for those scheduled for minor inpatient surgery.</measure>
      <time_frame>1 - 7 days prior to surgery</time_frame>
      <description>Sleep efficiency: defined as % sleep efficiency (ranging from 0-100)</description>
    </other_outcome>
    <other_outcome>
      <measure>Sleep efficiency as measured at baseline by wearable device for those scheduled for outpatient surgery.</measure>
      <time_frame>1 - 7 days prior to surgery</time_frame>
      <description>Sleep efficiency: defined as % sleep efficiency (ranging from 0-100)</description>
    </other_outcome>
    <other_outcome>
      <measure>Sleep efficiency as measured by wearable device for those scheduled for outpatient surgery.</measure>
      <time_frame>7 - 10 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable&#xD;
  Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)</description>
    </other_outcome>
    <other_outcome>
      <measure>Sleep efficiency as measured by wearable device for those scheduled for minor inpatient surgery.</measure>
      <time_frame>7 - 10 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable&#xD;
  Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)</description>
    </other_outcome>
    <other_outcome>
      <measure>Sleep efficiency as measured by wearable device for those scheduled for major inpatient surgery.</measure>
      <time_frame>7 - 10 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable&#xD;
  Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)</description>
    </other_outcome>
    <other_outcome>
      <measure>Sleep efficiency as measured by wearable device for those scheduled for major inpatient surgery.</measure>
      <time_frame>30 - 34 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable&#xD;
  Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)</description>
    </other_outcome>
    <other_outcome>
      <measure>Sleep efficiency as measured by wearable device for those scheduled for minor inpatient surgery.</measure>
      <time_frame>30 - 34 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable&#xD;
  Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)</description>
    </other_outcome>
    <other_outcome>
      <measure>Sleep efficiency as measured by wearable device for those scheduled for outpatient surgery.</measure>
      <time_frame>30 - 34 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable&#xD;
  Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)</description>
    </other_outcome>
    <other_outcome>
      <measure>Midpoint of sleep as measured at baseline by wearable device for those scheduled for outpatient surgery.</measure>
      <time_frame>1 - 7 days prior to surgery</time_frame>
      <description>Midpoint of sleep: defined as midpoint of sleep (time)</description>
    </other_outcome>
    <other_outcome>
      <measure>Midpoint of sleep as measured at baseline by wearable device for those scheduled for minor inpatient surgery.</measure>
      <time_frame>1 - 7 days prior to surgery</time_frame>
      <description>Midpoint of sleep: defined as midpoint of sleep (time)</description>
    </other_outcome>
    <other_outcome>
      <measure>Midpoint of sleep as measured at baseline by wearable device for those scheduled for major inpatient surgery.</measure>
      <time_frame>1 - 7 days prior to surgery</time_frame>
      <description>Midpoint of sleep: defined as midpoint of sleep (time)</description>
    </other_outcome>
    <other_outcome>
      <measure>Midpoint of sleep as measured by wearable device for those scheduled for major inpatient surgery.</measure>
      <time_frame>7 - 10 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device&#xD;
  Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)</description>
    </other_outcome>
    <other_outcome>
      <measure>Midpoint of sleep as measured by wearable device for those scheduled for minor inpatient surgery.</measure>
      <time_frame>7 - 10 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device&#xD;
  Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)</description>
    </other_outcome>
    <other_outcome>
      <measure>Midpoint of sleep as measured by wearable device for those scheduled for outpatient surgery.</measure>
      <time_frame>7 - 10 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device&#xD;
  Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)</description>
    </other_outcome>
    <other_outcome>
      <measure>Midpoint of sleep as measured by wearable device for those scheduled for outpatient surgery.</measure>
      <time_frame>30 - 34 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device&#xD;
  Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)</description>
    </other_outcome>
    <other_outcome>
      <measure>Midpoint of sleep as measured by wearable device for those scheduled for minor inpatient surgery.</measure>
      <time_frame>30 - 34 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device&#xD;
  Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)</description>
    </other_outcome>
    <other_outcome>
      <measure>Midpoint of sleep as measured by wearable device for those scheduled for major inpatient surgery.</measure>
      <time_frame>30 - 34 days after surgery</time_frame>
      <description>Measurement of outcomes will be median values measured on their wearable device&#xD;
  Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">12500</enrollment>
    <condition>Surgery-Complications</condition>
    <condition>Anesthesia Complication</condition>
    <condition>Anesthesia Awareness</condition>
    <condition>Anesthesia</condition>
    <condition>Surgery</condition>
    <condition>Quality of Life</condition>
    <condition>Pain, Postoperative</condition>
    <condition>Anesthesia Morbidity</condition>
    <condition>Depression</condition>
    <condition>Sleep Disorders, Circadian Rhythm</condition>
    <arm_group>
      <arm_group_label>Propofol total intravenous anesthesia (TIVA)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>No administration of inhaled agent.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>inhaled volatile general anesthesia (INVA)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Must administer inhaled agent.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Anesthetic technique Propofol TIVA</intervention_name>
      <description>Propofol TIVA no inhaled agent</description>
      <arm_group_label>Propofol total intravenous anesthesia (TIVA)</arm_group_label>
      <other_name>Propofol TIVA</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Anesthetic technique inhaled agent</intervention_name>
      <description>Must administer inhaled agent.</description>
      <arm_group_label>inhaled volatile general anesthesia (INVA)</arm_group_label>
      <other_name>Inhaled agent</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria&#xD;
  &#xD;
          Each patient must meet all of the following criteria:&#xD;
  &#xD;
            1. Aged 18 years or older&#xD;
  &#xD;
            2. Undergoing elective non-cardiac surgery expected to last ≥ 60 min requiring general&#xD;
               anesthesia with a tracheal tube or laryngeal mask airway (or similar supra-glottic&#xD;
               device)&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
          Patients will not be enrolled if any of the following criteria are met:&#xD;
  &#xD;
            1. Inability to provide informed consent in English (at all study sites) or Spanish (at&#xD;
               sites where Spanish consent is provided as an option)&#xD;
  &#xD;
            2. Pregnancy (based on patient report or positive test on the day of surgery)&#xD;
  &#xD;
            3. Surgical procedure requiring general, regional, neuraxial anesthesia administered by&#xD;
               an anesthesia clinician (anesthesiologist, CRNA, anesthesiology assistant) occurring&#xD;
               within 30 days prior to or planned to occur within 30 days after surgery date&#xD;
  &#xD;
            4. Contraindication to propofol TIVA or INVA (for example, documented allergy to&#xD;
               propofol, history of severe postoperative nausea or vomiting, concern for or history&#xD;
               of malignant hyperthermia) based on self-report&#xD;
  &#xD;
            5. Surgical procedures requiring a specific general anesthesia technique (for example,&#xD;
               TIVA required for neuromonitoring).&#xD;
  &#xD;
            6. Locally approved, written protocol mandating a particular anesthetic technique&#xD;
  &#xD;
            7. History of intraoperative awareness during general anesthesia based on patient&#xD;
               self-report&#xD;
  &#xD;
            8. Planned postoperative intubation&#xD;
  &#xD;
            9. Current incarceration&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Michael S Avidan, MBBcH</last_name>
      <role>Principal Investigator</role>
      <affiliation>Washington University School of Medicine</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sachin Kheterpal, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Michigan</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Laura Swisher</last_name>
      <phone>314-286-1024</phone>
      <email>goodl@wustl.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sherry McKinnon</last_name>
      <phone>314-286-1024</phone>
      <email>smckinnon@wustl.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Michigan</name>
        <address>
          <city>Ann Arbor</city>
          <state>Michigan</state>
          <zip>48109</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Allison Janda, MD</last_name>
        <email>ajanda@med.umich.edu</email>
      </contact>
      <contact_backup>
        <last_name>Rachel Shoemake</last_name>
        <email>rahersho@med.umich.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Sachin Kheterpal, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Allison Janda, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Sathish Kumar, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Washington University School of Medicine</name>
        <address>
          <city>Saint Louis</city>
          <state>Missouri</state>
          <zip>63110</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Laura Swisher</last_name>
        <email>goodl@wustl.edu</email>
      </contact>
      <contact_backup>
        <last_name>Sherry McKinnon, MS</last_name>
        <email>smckinnon@wustl.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Michael S Avidan, MBBch</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Stephen Gregory, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Washington University School of Medicine</investigator_affiliation>
      <investigator_full_name>Michael Avidan</investigator_full_name>
      <investigator_title>Professor of Anesthesiology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sleep Wake Disorders</mesh_term>
      <mesh_term>Sleep Disorders, Circadian Rhythm</mesh_term>
      <mesh_term>Pain, Postoperative</mesh_term>
      <mesh_term>Intraoperative Awareness</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Propofol</mesh_term>
      <mesh_term>Anesthetics</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05991453
  org study id: 202304082
  nct id: NCT05991453
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The investigators will conduct a 12,500-patient randomized multi-center trial to determine
        (i) which general anesthesia technique yields superior patient recovery experiences in any of
        three surgical categories ((a) major inpatient surgery, (b) minor inpatient surgery, (c)
        outpatient surgery) and (ii) whether TIVA confers no more than a small (0.2 %) increased risk
        of intraoperative awareness than INVA in patients undergoing both outpatient and inpatient
        surgeries
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Quality of Recovery-15 (QOR 15) score on POD1 after Major inpatient surgery
  time frame: baseline to day 1
  description: We will compare the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD1 and assess the difference between scores. A large difference between the baseline and POD1 score may indicate significant impact on quality of recovery after surgery type.
  Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
  measure: Quality of Recovery-15 score on POD1 after minor inpatient surgery
  time frame: baseline to day 1
  description: We will compare the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) minor inpatient surgery. taken by the participant at baseline and then again at POD1 and assess the difference between scores. A large difference between the baseline and POD1 score may indicate significant impact on quality of recovery after surgery type.
  Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
  measure: Quality of Recovery-15 score on POD1 after Outpatient surgery
  time frame: baseline to day 1
  description: We will compare the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) outpatient surgery. taken by the participant at baseline and then again at POD1 and assess the difference between scores. A large difference between the baseline and POD1 score may indicate significant impact on quality of recovery after surgery type.
  Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
  measure: Incidence of unintended intraoperative awareness with recall on POD1 or POD30
  time frame: 30 days
  description: Determine whether the incidence of intraoperative awareness with TIVA is non-inferior to that with INVA. Otherwise stated, to determine whether TIVA confers no more than a small (0.2%) increased risk of intraoperative awareness than INVA.
  measure: Quality of Recovery-15 score on POD0 after major inpatient surgery
  time frame: 7 days
  description: We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD0 and assess the difference between scores. A large difference between the baseline and POD0 score may indicate significant impact on quality of recovery after surgery type.
  Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
  measure: Quality of Recovery-15 score on POD0 minor inpatient surgery
  time frame: 7 days
  description: We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) minor inpatient surgery. taken by the participant at baseline and then again at POD0 and assess the difference between scores. A large difference between the baseline and POD0 score may indicate significant impact on quality of recovery after surgery type.
  Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
  measure: Quality of Recovery-15 score on POD0 outpatient surgery
  time frame: 7 days
  description: We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) out[atient surgery. taken by the participant at baseline and then again at POD0 and assess the difference between scores. A large difference between the baseline and POD0 score may indicate significant impact on quality of recovery after surgery type.
  Difference in baseline versus POD# (POD0, POD1, POD7) will be compared and assessed over the participants time in the study to measure the rate the participant returns to baseline QOR score.
  Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
  measure: Quality of Recovery-15 score on POD2 after major inpatient surgery
  time frame: 7 days
  description: We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD2 and assess the difference between scores. A large difference between the baseline and POD2 score may indicate significant impact on quality of recovery after surgery type.
  Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
  measure: Quality of Recovery-15 score on POD2 after minor inpatient surgery
  time frame: 7 days
  description: We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a)minor inpatient surgery. taken by the participant at baseline and then again at POD2 and assess the difference between scores. A large difference between the baseline and POD2 score may indicate significant impact on quality of recovery after surgery type.
  Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
  measure: Quality of Recovery-15 score on POD2 after outpatient surgery
  time frame: 7 days
  description: We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) outpatient surgery. taken by the participant at baseline and then again at POD2 and assess the difference between scores. A large difference between the baseline and POD2 score may indicate significant impact on quality of recovery after surgery type.
  Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
  measure: Quality of Recovery-15 score on POD7 after major inpatient surgery
  time frame: 7 days
  description: We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) major inpatient surgery. taken by the participant at baseline and then again at POD7 and assess the difference between scores. A large difference between the baseline and POD7 score may indicate significant impact on quality of recovery after surgery type.
  Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
  measure: Quality of Recovery-15 score on POD7 after minor inpatient surgery
  time frame: 7 days
  description: We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) minor inpatient surgery. taken by the participant at baseline and then again at POD7 and assess the difference between scores. A large difference between the baseline and POD7 score may indicate significant impact on quality of recovery after surgery type.
  Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
  measure: Quality of Recovery-15 score on POD7 after outpatient surgery
  time frame: 7 days
  description: We will compare the medium term trajectories of patient recovery using the QOR 15 following two commonly used and established anesthetic techniques, TIVA and INVA, in patients undergoing (a) out[aitnet surgery. taken by the participant at baseline and then again at POD7 and assess the difference between scores. A large difference between the baseline and POD7 score may indicate significant impact on quality of recovery after surgery type.
  Scoring: 0 - 150 points The higher the score the better quality of recovery is assumed.
  measure: Incidence of delirium on POD0 after major inpatient surgery
  time frame: 1 day
  description: Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing major inpatient surgery.
  measure: Incidence of delirium on POD0 after minor surgery
  time frame: 1 day
  description: Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing minor inpatient surgery.
  measure: Incidence of delirium on POD1 after major inpatient
  time frame: 1 day
  description: Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing outpatient surgery.
  measure: Incidence of delirium on POD1 after minor inpatient surgery
  time frame: 1 day
  description: Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing major inpatient surgery.
  measure: Incidence of delirium on POD1 after outpatient surgery
  time frame: 1 day
  description: Determine the incidence of delirium and change in quality of life after anesthesia and surgery following two commonly used and established anesthetic techniques: (1) TIVA with propofol and (2) INVA in patients undergoing outpatient surgery.
  measure: The Patient Health Questionnaire 4 (PHQ 4) on POD7 after major inpatient surgery
  time frame: 7 days
  description: The changes in anxiety and depression The PHQ - 4 is a screening test. A positive screen on each screening subscale causes the participant to be delivered the relevant full questionnaire of the PHQ 8.
  measure: The Patient Health Questionnaire 4 (PHQ 4) at baseline for those having major inpatient surgery
  time frame: 7 days
  description: The changes in anxiety and depression The PHQ - 4 is a screening test. A positive screen on each screening subscale causes the participant to be delivered the relevant full questionnaire of the PHQ 8.
  measure: The Patient Health Questionnaire 4 (PHQ 4) on POD7 after minor inpatient surgery
  time frame: 7 days
  description: The changes in anxiety and depression
  The PHQ - 4 is a screening test. A positive screen on each screening subscale causes the participant to be delivered the relevant full questionnaire of the PHQ 8.
  measure: The Patient Health Questionnaire 4 (PHQ 4) at baseline for those having minor inpatient surgery
  time frame: 7 days
  description: The changes in anxiety and depression
  The PHQ - 4 is a screening test. A positive screen on each screening subscale causes the participant to be delivered the relevant full questionnaire of the PHQ 8.
  measure: The Patient Health Questionnaire 4 (PHQ 4) on POD7 after outpatient surgery
  time frame: 7 days
  description: The changes in anxiety and depression
  The PHQ - 4 is a screening test. A positive screen on each screening subscale causes the participant to be delivered the relevant full questionnaire of the PHQ 8.
  measure: The Patient Health Questionnaire 4 (PHQ 4) at baseline for those having outpatient surgery.
  time frame: 7 days
  description: The changes in anxiety and depression
  The PHQ - 4 is a screening test. A positive screen on each screening subscale causes the participant to be delivered the relevant full questionnaire of the PHQ 8.
  measure: The Patient Health Questionnaire 8 (PHQ 8) on POD7 after minor inpatient surgery
  time frame: 7 days
  description: The changes in anxiety and depression
  The PHQ-8: Score is the sum of the 8 items. A higher score indicates the possible presence of depression.
  measure: The Patient Health Questionnaire 8 (PHQ 8) at baseline for those having minor inpatient surgery..
  time frame: 7 days
  description: The changes in anxiety and depression
  The PHQ-8: Score is the sum of the 8 items. A higher score indicates the possible presence of depression.
  measure: The Patient Health Questionnaire 8 (PHQ 8) on POD7 after major inpatient surgery
  time frame: 7 days
  description: The changes in anxiety and depression
  The PHQ-8: Score is the sum of the 8 items. A higher score indicates the possible presence of depression.
  measure: The Patient Health Questionnaire 8 (PHQ 8) at baseline for those having major inpatient surgery
  time frame: 7 days
  description: The changes in anxiety and depression
  The PHQ-8: Score is the sum of the 8 items. A higher score indicates the possible presence of depression.
  measure: The Patient Health Questionnaire 8 (PHQ 8) on POD7 after outpatient surgery
  time frame: 7 days
  description: The changes in anxiety and depression
  The PHQ-8: Score is the sum of the 8 items. A higher score indicates the possible presence of depression.
  measure: The Patient Health Questionnaire 8 (PHQ 8) at baseline for those having outpatient surgery
  time frame: 7 days
  description: The changes in anxiety and depression
  The PHQ-8: Score is the sum of the 8 items. A higher score indicates the possible presence of depression.
  measure: Generalized Anxiety Disorder - 7 (GAD 7) on POD7 after minor inpatient surgery
  time frame: 7 days
  description: Generalized Anxiety Disorder - 7 (GAD 7) Scoring: Score is the sum of the 7 items. Higher scores indicate the presence of anxiety.
  measure: Generalized Anxiety Disorder - 7 (GAD 7) at baseline for those having minor inpatient surgery
  time frame: 7 days
  description: Generalized Anxiety Disorder - 7 (GAD 7) Scoring: Score is the sum of the 7 items. Higher scores indicate the presence of anxiety.
  measure: Generalized Anxiety Disorder - 7 (GAD 7) on POD7 after major inpatient surgery
  time frame: 7 days
  description: Generalized Anxiety Disorder - 7 (GAD 7) Scoring: Score is the sum of the 7 items. Higher scores indicate the presence of anxiety.
  measure: Generalized Anxiety Disorder - 7 (GAD 7) at baseline for those having major inpatient surgery
  time frame: 7 days
  description: Generalized Anxiety Disorder - 7 (GAD 7) Scoring: Score is the sum of the 7 items. Higher scores indicate the presence of anxiety.
  measure: Generalized Anxiety Disorder - 7 (GAD 7) on POD7 after outpatient surgery
  time frame: 7 days
  description: Generalized Anxiety Disorder - 7 (GAD 7) Scoring: Score is the sum of the 7 items. Higher scores indicate the presence of anxiety.
  measure: Generalized Anxiety Disorder - 7 (GAD 7) at baseline for those having outpatient surgery
  time frame: 7 days
  description: Generalized Anxiety Disorder - 7 (GAD 7) Scoring: Score is the sum of the 7 items. Higher scores indicate the presence of anxiety.
  measure: Days alive and at-home at POD30 after major inpatient surgery
  time frame: 30 days
  description: The patient will be asked if they were re-admitted to the hospital after the index surgery. If yes, the numbers of days in the hospital will be recorded.
  measure: Days alive and at-home at POD30 after minor inpatient surgery
  time frame: 30 days
  description: The patient will be asked if they were re-admitted to the hospital after the index surgery. If yes, the numbers of days in the hospital will be recorded.
  measure: EQ-5D-5L Quality of life on POD30 after major inpatient surgery
  time frame: 30 days
  description: EQ-5D-5L Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.
  EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
  measure: EQ-5D-5L Quality of life on POD30 after minor inpatient surgery
  time frame: 30 days
  description: Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.
  EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
  measure: EQ-5D-5L Quality of life on POD30 after outpatient surgery
  time frame: 30 days
  description: Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.
  EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
  measure: EQ-5D-5L Quality of life on POD90 after major inpatient surgery
  time frame: 90 days
  description: Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.
  EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
  measure: EQ-5D-5L Quality of life on POD90 after minor inpatient surgery
  time frame: 90 days
  description: Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.
  EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
  measure: EQ-5D-5L Quality of life on POD90 after outpatient surgery
  time frame: 90 days
  description: Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.
  EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
  measure: EQ-5D-5L Quality of life on POD180 after major inpatient surgery
  time frame: 180 days
  description: Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.
  EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
  measure: EQ-5D-5L Quality of life on POD180 after minor inpatient surgery
  time frame: 180 days
  description: Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.
  EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
  measure: EQ-5D-5L Quality of life on POD180 after outpatient surgery
  time frame: 180 days
  description: Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.
  EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
  measure: EQ-5D-5L Quality of life on POD365 after major inpatient surgery
  time frame: 365 days
  description: Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.
  EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
  measure: EQ - 5D-5L Quality of life on POD365 after minor inpatient surgery
  time frame: 365 days
  description: Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.
  EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
  measure: EQ-5D-5L Quality of life on POD365 after out patient surgery
  time frame: 365 days
  description: Measure of quality of life. Score at baseline will be compared to scores at stated timepoints to assess decrease and recovery of QOL measures over time.
  EQ-5D-5L is a nuanced measure of quality of life on different domains. For scoring guidelines please see the manual https://euroqol.org/wp-content/uploads/2023/03/EQ-5D-5LUserguide-08-0421.pdf
  measure: Bauer Questionnaire - Patient satisfaction with anesthesia at POD2
  time frame: 2 days
  description: Bauer questionnaire - Self-report satisfaction survey focused on satisfaction with anesthesia. Satisfaction is measured by reporting an experience as happening and if it did was it moderate or severe. As well as satisfaction for each aspect of anesthesia care:
  "very satisfied", "satisfied", "dissatisfied", or "very dissatisfied"
  measure: Respiratory failure on POD0
  time frame: 1 day
  description: Respiratory failure on POD0
  measure: kidney injury on POD7
  time frame: 7 days
  description: kidney injury on POD7
  measure: all-cause mortality at POD30
  time frame: 30 days
  description: all-cause mortality at POD30
  measure: all-cause mortality at POD90
  time frame: 90 days
  description: all-cause mortality at POD90
  measure: intraoperative hypotension
  time frame: 90 days
  description: intraoperative hypotension
  measure: moderate to severe intraoperative patient movement
  time frame: 90 days
  description: moderate to severe intraoperative patient movement
  measure: unplanned admission after outpatient surgery in an ambulatory setting
  time frame: 90 days
  description: unplanned admission after outpatient surgery in an ambulatory setting
  measure: Incidence of propofol-related infusion syndrome, and malignant hyperthermia as reported in the EHR
  time frame: 90 days
  description: Incidence of propofol-related infusion syndrome, and malignant hyperthermia as reported in the EHR
  measure: Incidence of malignant hyperthermia as reported in the EHR
  time frame: 90 days
  description: Incidence of malignant hyperthermia as reported in the EHR
  measure: Daily step count as measured by wearable device at baseline for those scheduled for major inpatient surgery.
  time frame: 1 - 7 days prior to surgery
  description: Daily step count at baseline - number of steps per day
  measure: Daily step count as measured by wearable device at baseline for those scheduled for minor inpatient surgery.
  time frame: 1 - 7 days prior to surgery
  description: Daily step count at baseline - number of steps per day
  measure: Daily step count as measured by wearable device at baseline for those scheduled for outpatient surgery.
  time frame: 1 - 7 days prior to surgery
  description: Daily step count at baseline - number of steps per day
  measure: Daily step count as measured by wearable device for those scheduled for outpatient surgery.
  time frame: 7 - 10 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day
  measure: Daily step count as measured by wearable device for those scheduled for major inpatient surgery.
  time frame: 7 - 10 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day
  measure: Daily step count as measured by wearable device for those scheduled for minor inpatient surgery.
  time frame: 7 - 10 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day
  measure: Daily step count as measured by wearable device for those scheduled for minor inpatient surgery.
  time frame: 30 - 34 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day
  measure: Daily step count as measured by wearable device for those scheduled for major inpatient surgery.
  time frame: 30 - 34 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day
  measure: Daily step count as measured by wearable device for those scheduled for outpatient surgery.
  time frame: 30 - 34 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device Daily step count: Proportion of patients within 10% of baseline, defined as steps per day
  measure: Daily standing hours as measured by wearable device at baseline for those scheduled for major inpatient surgery.
  time frame: 1 - 7 days prior to surgery
  description: Daily standing hours: defined as standing hours per day
  measure: Daily standing hours as measured by wearable device at baseline for those scheduled for minor inpatient surgery.
  time frame: 1 - 7 days prior to surgery
  description: Daily standing hours: defined as standing hours per day
  measure: Daily standing hours as measured by wearable device at baseline for those scheduled for outpatient surgery.
  time frame: 1 - 7 days prior to surgery
  description: Daily standing hours: defined as standing hours per day
  measure: Daily standing hours as measured by wearable device for those scheduled for outpatient surgery.
  time frame: 7 - 10 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device.
  Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day
  measure: Daily standing hours as measured by wearable device for those scheduled for major inpatient surgery.
  time frame: 7 - 10 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device.
  Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day
  measure: Daily standing hours as measured by wearable device for those scheduled for minor inpatient surgery.
  time frame: 7 - 10 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device.
  Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day
  measure: Daily standing hours as measured by wearable device for those scheduled for minor inpatient surgery.
  time frame: 30 - 34 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device.
  Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day
  measure: Daily standing hours as measured by wearable device for those scheduled for major inpatient surgery.
  time frame: 30 - 34 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device.
  Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day
  measure: Daily standing hours as measured by wearable device for those scheduled for outpatient surgery.
  time frame: 30 - 34 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device.
  Daily standing hours: Proportion of patients within 10% of baseline, defined as standing hours per day
  measure: Total sleep time as measured at baseline by wearable device for those scheduled for outpatient surgery.
  time frame: 1 - 7 days prior to surgery
  description: Total sleep time defined as minutes of total sleep time per day
  measure: Total sleep time as measured at baseline by wearable device for those scheduled for major inpatient surgery.
  time frame: 1 - 7 days prior to surgery
  description: Total sleep time defined as minutes of total sleep time per day
  measure: Total sleep time as measured at baseline by wearable device for those scheduled for minor inpatient surgery.
  time frame: 1 - 7 days prior to surgery
  description: Total sleep time defined as minutes of total sleep time per day
  measure: Total sleep time as measured by wearable device for those scheduled for minor inpatient surgery.
  time frame: 7 - 10 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device
  Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day
  measure: Total sleep time as measured by wearable device for those scheduled for major inpatient surgery.
  time frame: 7 - 10 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device
  Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day
  measure: Total sleep time as measured by wearable device for those scheduled for outpatient surgery.
  time frame: 7 - 10 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device
  Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day
  measure: Total sleep time as measured by wearable device for those scheduled for outpatient surgery.
  time frame: 30 - 34 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device
  Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day
  measure: Total sleep time as measured by wearable device for those scheduled for major inpatient surgery.
  time frame: 30 - 34 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device
  Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day
  measure: Total sleep time as measured by wearable device for those scheduled for minor inpatient surgery.
  time frame: 30 - 34 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device
  Total sleep time: Proportion of patients within 10% of baseline, defined as minutes of total sleep time per day
  measure: Sleep onset latency as measured by wearable device at baseline for those scheduled for minor inpatient surgery.
  time frame: 1 - 7 days prior to surgery
  description: Sleep onset latency: defined as minutes of sleep onset latency per day
  measure: Sleep onset latency as measured by wearable device at baseline for those scheduled for major inpatient surgery.
  time frame: 1 - 7 days prior to surgery
  description: Sleep onset latency: defined as minutes of sleep onset latency per day
  measure: Sleep onset latency as measured by wearable device at baseline for those scheduled for outpatient surgery.
  time frame: 1 - 7 days prior to surgery
  description: Sleep onset latency: defined as minutes of sleep onset latency per day
  measure: Sleep onset latency as measured by wearable device for those scheduled for outpatient surgery.
  time frame: 7 - 10 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device
  Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day
  measure: Sleep onset latency as measured by wearable device for those scheduled for minor inpatient surgery.
  time frame: 7 - 10 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device
  Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day
  measure: Sleep onset latency as measured by wearable device for those scheduled for major inpatient surgery.
  time frame: 7 - 10 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device
  Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day
  measure: Sleep onset latency as measured by wearable device for those scheduled for major inpatient surgery.
  time frame: 30 - 34 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device
  Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day
  measure: Sleep onset latency as measured by wearable device for those scheduled for minor inpatient surgery.
  time frame: 30 - 34 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device
  Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day
  measure: Sleep onset latency as measured by wearable device for those scheduled for outpatient surgery.
  time frame: 30 - 34 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device
  Sleep onset latency: Proportion of patients within 10% of baseline, defined as minutes of sleep onset latency per day
  measure: Wake after sleep onset as measured by wearable device for those scheduled for outpatient surgery.
  time frame: 1 - 7 days prior to surgery
  description: Wake after sleep onset: defined as minutes of wake after sleep onset
  measure: Wake after sleep onset as measured by wearable device for those scheduled for major inpatient surgery.
  time frame: 1 - 7 days prior to surgery
  description: Wake after sleep onset: defined as minutes of wake after sleep onset
  measure: Wake after sleep onset as measured by wearable device for those scheduled for minor inpatient surgery.
  time frame: 1 - 7 days prior to surgery
  description: Wake after sleep onset: defined as minutes of wake after sleep onset
  measure: Wake after sleep onset as measured by wearable device for those scheduled for minor inpatient surgery.
  time frame: 7 - 10 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device
  Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset
  measure: Wake after sleep onset as measured by wearable device for those scheduled for major inpatient surgery.
  time frame: 7 - 10 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device
  Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset
  measure: Wake after sleep onset as measured by wearable device for those scheduled for outpatient surgery.
  time frame: 7 - 10 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device
  Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset
  measure: Wake after sleep onset as measured by wearable device for those scheduled for outpatient surgery.
  time frame: 30 - 34 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device
  Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset
  measure: Wake after sleep onset as measured by wearable device for those scheduled for minor inpatient surgery.
  time frame: 30 - 34 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device
  Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset
  measure: Wake after sleep onset as measured by wearable device for those scheduled for major inpatient surgery.
  time frame: 30 - 34 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device
  Wake after sleep onset: Proportion of patients within 10% of baseline, defined as minutes of wake after sleep onset
  measure: Sleep efficiency as measured at baseline by wearable device for those scheduled for major inpatient surgery.
  time frame: 1 - 7 days prior to surgery
  description: Sleep efficiency: defined as % sleep efficiency (ranging from 0-100)
  measure: Sleep efficiency as measured at baseline by wearable device for those scheduled for minor inpatient surgery.
  time frame: 1 - 7 days prior to surgery
  description: Sleep efficiency: defined as % sleep efficiency (ranging from 0-100)
  measure: Sleep efficiency as measured at baseline by wearable device for those scheduled for outpatient surgery.
  time frame: 1 - 7 days prior to surgery
  description: Sleep efficiency: defined as % sleep efficiency (ranging from 0-100)
  measure: Sleep efficiency as measured by wearable device for those scheduled for outpatient surgery.
  time frame: 7 - 10 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable
  Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)
  measure: Sleep efficiency as measured by wearable device for those scheduled for minor inpatient surgery.
  time frame: 7 - 10 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable
  Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)
  measure: Sleep efficiency as measured by wearable device for those scheduled for major inpatient surgery.
  time frame: 7 - 10 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable
  Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)
  measure: Sleep efficiency as measured by wearable device for those scheduled for major inpatient surgery.
  time frame: 30 - 34 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable
  Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)
  measure: Sleep efficiency as measured by wearable device for those scheduled for minor inpatient surgery.
  time frame: 30 - 34 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable
  Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)
  measure: Sleep efficiency as measured by wearable device for those scheduled for outpatient surgery.
  time frame: 30 - 34 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable
  Sleep efficiency: Proportion of patients within 10% of baseline, defined as % sleep efficiency (ranging from 0-100)
  measure: Midpoint of sleep as measured at baseline by wearable device for those scheduled for outpatient surgery.
  time frame: 1 - 7 days prior to surgery
  description: Midpoint of sleep: defined as midpoint of sleep (time)
  measure: Midpoint of sleep as measured at baseline by wearable device for those scheduled for minor inpatient surgery.
  time frame: 1 - 7 days prior to surgery
  description: Midpoint of sleep: defined as midpoint of sleep (time)
  measure: Midpoint of sleep as measured at baseline by wearable device for those scheduled for major inpatient surgery.
  time frame: 1 - 7 days prior to surgery
  description: Midpoint of sleep: defined as midpoint of sleep (time)
  measure: Midpoint of sleep as measured by wearable device for those scheduled for major inpatient surgery.
  time frame: 7 - 10 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device
  Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)
  measure: Midpoint of sleep as measured by wearable device for those scheduled for minor inpatient surgery.
  time frame: 7 - 10 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device
  Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)
  measure: Midpoint of sleep as measured by wearable device for those scheduled for outpatient surgery.
  time frame: 7 - 10 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device
  Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)
  measure: Midpoint of sleep as measured by wearable device for those scheduled for outpatient surgery.
  time frame: 30 - 34 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device
  Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)
  measure: Midpoint of sleep as measured by wearable device for those scheduled for minor inpatient surgery.
  time frame: 30 - 34 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device
  Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)
  measure: Midpoint of sleep as measured by wearable device for those scheduled for major inpatient surgery.
  time frame: 30 - 34 days after surgery
  description: Measurement of outcomes will be median values measured on their wearable device
  Midpoint of sleep: Proportion of patients within 60 minutes of baseline, defined as midpoint of sleep (time)
  arm group label: Propofol total intravenous anesthesia (TIVA)
  arm group type: Active Comparator
  description: No administration of inhaled agent.
  arm group label: inhaled volatile general anesthesia (INVA)
  arm group type: Active Comparator
  description: Must administer inhaled agent.
  intervention type: Other
  intervention name: Anesthetic technique Propofol TIVA
  description: Propofol TIVA no inhaled agent
  arm group label: Propofol total intravenous anesthesia (TIVA)
  other name: Propofol TIVA
  intervention type: Other
  intervention name: Anesthetic technique inhaled agent
  description: Must administer inhaled agent.
  arm group label: inhaled volatile general anesthesia (INVA)
  other name: Inhaled agent
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Michael S Avidan, MBBcH
  role: Principal Investigator
  affiliation: Washington University School of Medicine
  last name: Sachin Kheterpal, MD
  role: Principal Investigator
  affiliation: University of Michigan
  last name: Laura Swisher
  phone: 314-286-1024
  email: goodl@wustl.edu
  last name: Sherry McKinnon
  phone: 314-286-1024
  email: smckinnon@wustl.edu
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
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  investigator: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Washington University School of Medicine
  investigator full name: Michael Avidan
  investigator title: Professor of Anesthesiology
  mesh term: Sleep Wake Disorders
  mesh term: Sleep Disorders, Circadian Rhythm
  mesh term: Pain, Postoperative
  mesh term: Intraoperative Awareness
  mesh term: Propofol
  mesh term: Anesthetics