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/NCT05990790</url>
    </required_header>
    <id_info>
      <org_study_id>RAPIDII_01</org_study_id>
      <nct_id>NCT05990790</nct_id>
    </id_info>
    <brief_title>The Effect of Desflurane Versus Sevoflurane Versus Propofol on Postoperative Delirium</brief_title>
    <acronym>RAPID-II</acronym>
    <official_title>The Effect of Desflurane Versus Sevoflurane Versus Propofol on Postoperative Delirium in Elderly Patients Undergoing Moderate- to High-risk Major Noncardiac Surgery - a Prospective, Observer-blinded, Randomized, Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of Vienna</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medical University of Vienna</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>
        Patients over the age of 65 years are at increased risk for developing delirium after&#xD;
        noncardiac surgeries, resulting in increased morbidity and mortality. The prevention of&#xD;
        postoperative delirium has been classified as a public health priority. However, so far data&#xD;
        regarding possible intraoperative interventions to reduce the incidence of postoperative&#xD;
        delirium is very scarce. Due to the more rapid wash-in and wash-out times of desflurane as&#xD;
        compared to sevoflurane or propofol it seems reasonable that desflurane might be beneficial&#xD;
        for the prevention of postoperative delirium. Therefore, we evaluate the effect of&#xD;
        maintenance of anesthesia using desflurane, sevoflurane or propofol on postoperative delirium&#xD;
        in elderly patients undergoing moderate- to high-risk major noncardiac surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: Postoperative delirium occurs in approximately 25% of patients over the age of 60&#xD;
        years undergoing major noncardiac surgery and is significantly associated with an increase in&#xD;
        postoperative neurocognitive decline, morbidity, and mortality. The prevention of&#xD;
        postoperative delirium has been classified as a public health priority. However, so far data&#xD;
        regarding possible intraoperative interventions to reduce the incidence of postoperative&#xD;
        delirium is very scarce. Previous small studies compared the effect of administration of&#xD;
        sevoflurane versus propofol for maintenance of anesthesia on postoperative delirium and found&#xD;
        beneficial effects of volatile anesthesia for the prevention of postoperative delirium.&#xD;
        Furthermore, in small studies the administration of desflurane led to significantly shorter&#xD;
        recovery periods after noncardiac surgery as compared to sevoflurane. Due to the more rapid&#xD;
        wash-in and wash-out times of desflurane as compared to sevoflurane or propofol it seems&#xD;
        reasonable that desflurane might be beneficial for the prevention of postoperative delirium.&#xD;
        Therefore, we evaluate the effect of maintenance of anesthesia using desflurane, sevoflurane&#xD;
        or propofol on postoperative delirium in elderly patients undergoing moderate- to high-risk&#xD;
        major noncardiac surgery.&#xD;
  &#xD;
        Methods: We will include 1332 patients ≥ 65 years of age undergoing moderate- to high-risk&#xD;
        major noncardiac surgery lasting at least two hours in this prospective observer-blinded&#xD;
        randomized controlled clinical trial. After induction of anesthesia patients will be randomly&#xD;
        assigned to receive desflurane, sevoflurane or propofol for maintenance of anesthesia. Our&#xD;
        primary outcome will be the incidence of postoperative delirium in the first five&#xD;
        postoperative days. Postoperative delirium will be diagnosed using the 3D-CAM or 3D-CAM-ICU&#xD;
        in the morning and evening of the first five postoperative days as appropriate assessed by&#xD;
        blinded study personnel. Two-interim analyses after 1/3 and 2/3 of recruitment are&#xD;
        pre-planned.&#xD;
  &#xD;
        Statistics: The primary outcome, the incidence of postoperative delirium in the first five&#xD;
        postoperative days, will be compared between the groups using a Chi-Square-test as well as a&#xD;
        logistic regression model for the incidence of postoperative delirium will be performed&#xD;
        accounting for randomized group, age and other possible confounding factors.&#xD;
  &#xD;
        Level of originality: Data regarding possible intraoperative interventions for the prevention&#xD;
        of postoperative delirium are scarce. In detail, the effects of commonly used anesthetics on&#xD;
        the incidence of postoperative delirium and neurocognitive dysfunction have only been studied&#xD;
        in retrospective analyses or small prospective studies, which showed inconsistent results.&#xD;
        Nevertheless, delirium is a major event after surgery and is associated with postoperative&#xD;
        complications, worse neurocognitive recovery and increased mortality, especially in elderly&#xD;
        patients. Thus, the results of this trial will help to choose the right anesthetic according&#xD;
        to individual patients' requirements to reduce the risk for postoperative delirium in future.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 3, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2028</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2027</primary_completion_date>
    <phase>Phase 4</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>Prevention</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of postoperative delirium</measure>
      <time_frame>First five postoperative days</time_frame>
      <description>Delirium will be assessed via 3D-cognitive assessment method (3D-CAM) test as early in the morning as practical and in the early evening for the initial five postoperative days while the patients remain hospitalized according to current recommendations. In patients in the intensive care unit (ICU), we will perform the 3D-CAM-ICU. Any positive CAM test will be considered evidence of delirium, which will be analyzed dichotomously.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Digit Symbol-Substitution-Test for the incidence of postoperative cognitive dysfunction (POCD)</measure>
      <time_frame>First five postoperative days</time_frame>
      <description>POCD will be assessed using the Digit-Symbol-Substitution-Test (DSST). The occurrence of POCD will be defined when a patient has a Z score on two or all tests or the combined Z score is below -1.96 standard deviation (SD).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trail Making Test (TMT) for the incidence of postoperative cognitive dysfunction (POCD)</measure>
      <time_frame>First five postoperative days</time_frame>
      <description>POCD will be assessed using the Trail Making Test (TMT). The occurrence of POCD will be defined when a patient has a Z score on two or all tests or the combined Z score is below -1.96 standard deviation (SD).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative need of supplemental oxygen</measure>
      <time_frame>During PACU/ICU stay after surgery (max. of first 24 hours after surgery)</time_frame>
      <description>We will record postoperative need for administration of supplemental oxygen to maintain a SpO2 of 93% during PACU or ICU stay.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of stay in ICU</measure>
      <time_frame>First 30 days after surgery</time_frame>
      <description>Length of stay in ICU after surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Postoperative nausea and vomiting in the early postoperative period</measure>
      <time_frame>First two hours after surgery</time_frame>
      <description>Episode of nausea and/or vomiting within the first two hours after surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Postoperative nausea and vomiting in the late postoperative period</measure>
      <time_frame>First five postoperative days</time_frame>
      <description>Episode of nausea and/or vomiting from two hours after surgery until the fifth postoperative day.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intraoperative hypotension</measure>
      <time_frame>During surgery</time_frame>
      <description>Intraoperative duration of mean arterial pressure &lt;65mmHg and overall amount of intraoperatively administered catecholamines (including phenylephrine, norepinephrine, epinephrine, etilefrine, ephedrine).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Death within 5 days after surgery</measure>
      <time_frame>First five postoperative days</time_frame>
      <description>Mortality in the first five postoperative days.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Days at home in the first month after surgery</measure>
      <time_frame>First 30 days after surgery</time_frame>
      <description>Number of days at home within the first 30 postoperative days.</description>
    </other_outcome>
    <other_outcome>
      <measure>Long-term postoperative cognitive dysfunction</measure>
      <time_frame>One year after surgery</time_frame>
      <description>Long-term postoperative cognitive dysfunction will be assessed via Montreal cognitive assessment (MoCA). We will assess the baseline MoCA a day before surgery and one year after surgery via phone interview. Minimum score of the MoCA is 0 points. Maximum score of the MoCA is 22 points. Postoperative cognitive dysfunction is defined as a reduction of at least 2 points as compared to baseline.</description>
    </other_outcome>
    <other_outcome>
      <measure>Postoperative IL-6 concentrations (pg/ml)</measure>
      <time_frame>First two postoperative days</time_frame>
      <description>Postoperative area under the curve (AUC) within the first two postoperative days of concentrations of Interleukin 6 (IL-6).</description>
    </other_outcome>
    <other_outcome>
      <measure>Postoperative PCT concentrations (ng/ml)</measure>
      <time_frame>First two postoperative days</time_frame>
      <description>Postoperative area under the curve (AUC) within the first two postoperative days of concentrations of Procalcitonin (PCT).</description>
    </other_outcome>
    <other_outcome>
      <measure>Postoperative CRP concentrations (mg/dl)</measure>
      <time_frame>First two postoperative days</time_frame>
      <description>Postoperative area under the curve (AUC) within the first two postoperative days of concentrations of C-reactive protein (CRP).</description>
    </other_outcome>
    <other_outcome>
      <measure>Postoperative Copeptin concentrations (pmol/L)</measure>
      <time_frame>First two postoperative days</time_frame>
      <description>AUC within the first two postoperative days of concentrations of Copeptin.</description>
    </other_outcome>
    <other_outcome>
      <measure>Postoperative TnT concentrations (ng/L)</measure>
      <time_frame>First two postoperative days</time_frame>
      <description>AUC within the first two postoperative days of concentrations of TnT.</description>
    </other_outcome>
    <other_outcome>
      <measure>Postoperative NT-proBNP concentrations (pg/ml)</measure>
      <time_frame>First two postoperative days</time_frame>
      <description>AUC within the first two postoperative days of concentrations of NT-proBNP.</description>
    </other_outcome>
    <other_outcome>
      <measure>Postoperative S100-B concentrations (µg/L)</measure>
      <time_frame>First two postoperative days</time_frame>
      <description>AUC within the first two postoperative days of concentrations of S100-B.</description>
    </other_outcome>
    <other_outcome>
      <measure>Postoperative NSE concentrations (µg/L)</measure>
      <time_frame>First two postoperative days</time_frame>
      <description>AUC within the first two postoperative days of concentrations of NSE.</description>
    </other_outcome>
    <other_outcome>
      <measure>All-cause death within one year after surgery</measure>
      <time_frame>One year after surgery</time_frame>
      <description>All cause one-year mortality.</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">1332</enrollment>
    <condition>Postoperative Delirium</condition>
    <condition>Major Noncardiac Surgery</condition>
    <condition>Postoperative Cognitive Dysfunction</condition>
    <arm_group>
      <arm_group_label>Desflurane Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After induction of anesthesia, maintenance of anesthesia will be performed using goal-directed administration of desflurane with an intraoperative goal of bispectral index (BIS) 50±10.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sevoflurane Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>After induction of anesthesia, maintenance of anesthesia will be performed using goal-directed administration of sevoflurane with an intraoperative goal of bispectral index (BIS) 50±10.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Propofol Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>After induction of anesthesia, maintenance of anesthesia will be performed using goal-directed administration of propofol with an intraoperative goal of bispectral index (BIS) 50±10.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Desflurane</intervention_name>
      <description>After induction of anesthesia, maintenance of anesthesia will be performed using goal-directed administration of desflurane with an intraoperative goal of bispectral index (BIS) 50±10.</description>
      <arm_group_label>Desflurane Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sevoflurane</intervention_name>
      <description>After induction of anesthesia, maintenance of anesthesia will be performed using goal-directed administration of sevoflurane with an intraoperative goal of bispectral index (BIS) 50±10.</description>
      <arm_group_label>Sevoflurane Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Propofol</intervention_name>
      <description>After induction of anesthesia, maintenance of anesthesia will be performed using goal-directed administration of propofol with an intraoperative goal of bispectral index (BIS) 50±10.</description>
      <arm_group_label>Propofol Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Provide written informed consent&#xD;
  &#xD;
            -  ≥65 years of age&#xD;
  &#xD;
            -  Scheduled for elective major noncardiac surgery with estimated time of surgery ≥ 2&#xD;
               hours&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing emergency surgery&#xD;
  &#xD;
            -  BMI &gt; 45 kg/m^2&#xD;
  &#xD;
            -  History of diagnosed dementia&#xD;
  &#xD;
            -  Language, vision, or hearing impairments that may compromise cognitive assessments&#xD;
  &#xD;
            -  History of malignant hyperthermia&#xD;
  &#xD;
            -  History of structural muscle disease&#xD;
  &#xD;
            -  History of organ transplantation (kidney, liver, lung, heart)&#xD;
  &#xD;
            -  Patients undergoing hyperthermic intraperitoneal chemotherapy&#xD;
  &#xD;
            -  ICU patients undergoing surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Christian Reiterer, Prof. MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Medical University of Vienna</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alexander Taschner, MD</last_name>
      <phone>0043 1 40400</phone>
      <phone_ext>20760</phone_ext>
      <email>alexander.taschner@meduniwien.ac.at</email>
    </overall_contact>
    <location>
      <facility>
        <name>Medical University of Vienna</name>
        <address>
          <city>Vienna</city>
          <zip>1090</zip>
          <country>Austria</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Christian Reiterer, MD</last_name>
        <phone>0043 1 40400</phone>
        <phone_ext>20760</phone_ext>
        <email>christian.reiterer@meduniwien.ac.at</email>
      </contact>
    </location>
    <location_countries>
      <country>Austria</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
      <investigator_full_name>Christian Reiterer</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Propofol</keyword>
    <keyword>Sevoflurane</keyword>
    <keyword>Desflurane</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Delirium</mesh_term>
      <mesh_term>Emergence Delirium</mesh_term>
      <mesh_term>Postoperative Cognitive Complications</mesh_term>
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Propofol</mesh_term>
      <mesh_term>Sevoflurane</mesh_term>
      <mesh_term>Desflurane</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05990790
  org study id: RAPIDII_01
  nct id: NCT05990790
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Patients over the age of 65 years are at increased risk for developing delirium after
        noncardiac surgeries, resulting in increased morbidity and mortality. The prevention of
        postoperative delirium has been classified as a public health priority. However, so far data
        regarding possible intraoperative interventions to reduce the incidence of postoperative
        delirium is very scarce. Due to the more rapid wash-in and wash-out times of desflurane as
        compared to sevoflurane or propofol it seems reasonable that desflurane might be beneficial
        for the prevention of postoperative delirium. Therefore, we evaluate the effect of
        maintenance of anesthesia using desflurane, sevoflurane or propofol on postoperative delirium
        in elderly patients undergoing moderate- to high-risk major noncardiac surgery.
  Background: Postoperative delirium occurs in approximately 25% of patients over the age of 60
        years undergoing major noncardiac surgery and is significantly associated with an increase in
        postoperative neurocognitive decline, morbidity, and mortality. The prevention of
        postoperative delirium has been classified as a public health priority. However, so far data
        regarding possible intraoperative interventions to reduce the incidence of postoperative
        delirium is very scarce. Previous small studies compared the effect of administration of
        sevoflurane versus propofol for maintenance of anesthesia on postoperative delirium and found
        beneficial effects of volatile anesthesia for the prevention of postoperative delirium.
        Furthermore, in small studies the administration of desflurane led to significantly shorter
        recovery periods after noncardiac surgery as compared to sevoflurane. Due to the more rapid
        wash-in and wash-out times of desflurane as compared to sevoflurane or propofol it seems
        reasonable that desflurane might be beneficial for the prevention of postoperative delirium.
        Therefore, we evaluate the effect of maintenance of anesthesia using desflurane, sevoflurane
        or propofol on postoperative delirium in elderly patients undergoing moderate- to high-risk
        major noncardiac surgery.
  
        Methods: We will include 1332 patients ≥ 65 years of age undergoing moderate- to high-risk
        major noncardiac surgery lasting at least two hours in this prospective observer-blinded
        randomized controlled clinical trial. After induction of anesthesia patients will be randomly
        assigned to receive desflurane, sevoflurane or propofol for maintenance of anesthesia. Our
        primary outcome will be the incidence of postoperative delirium in the first five
        postoperative days. Postoperative delirium will be diagnosed using the 3D-CAM or 3D-CAM-ICU
        in the morning and evening of the first five postoperative days as appropriate assessed by
        blinded study personnel. Two-interim analyses after 1/3 and 2/3 of recruitment are
        pre-planned.
  
        Statistics: The primary outcome, the incidence of postoperative delirium in the first five
        postoperative days, will be compared between the groups using a Chi-Square-test as well as a
        logistic regression model for the incidence of postoperative delirium will be performed
        accounting for randomized group, age and other possible confounding factors.
  
        Level of originality: Data regarding possible intraoperative interventions for the prevention
        of postoperative delirium are scarce. In detail, the effects of commonly used anesthetics on
        the incidence of postoperative delirium and neurocognitive dysfunction have only been studied
        in retrospective analyses or small prospective studies, which showed inconsistent results.
        Nevertheless, delirium is a major event after surgery and is associated with postoperative
        complications, worse neurocognitive recovery and increased mortality, especially in elderly
        patients. Thus, the results of this trial will help to choose the right anesthetic according
        to individual patients' requirements to reduce the risk for postoperative delirium in future.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Outcomes Assessor)
  measure: Incidence of postoperative delirium
  time frame: First five postoperative days
  description: Delirium will be assessed via 3D-cognitive assessment method (3D-CAM) test as early in the morning as practical and in the early evening for the initial five postoperative days while the patients remain hospitalized according to current recommendations. In patients in the intensive care unit (ICU), we will perform the 3D-CAM-ICU. Any positive CAM test will be considered evidence of delirium, which will be analyzed dichotomously.
  measure: Digit Symbol-Substitution-Test for the incidence of postoperative cognitive dysfunction (POCD)
  time frame: First five postoperative days
  description: POCD will be assessed using the Digit-Symbol-Substitution-Test (DSST). The occurrence of POCD will be defined when a patient has a Z score on two or all tests or the combined Z score is below -1.96 standard deviation (SD).
  measure: Trail Making Test (TMT) for the incidence of postoperative cognitive dysfunction (POCD)
  time frame: First five postoperative days
  description: POCD will be assessed using the Trail Making Test (TMT). The occurrence of POCD will be defined when a patient has a Z score on two or all tests or the combined Z score is below -1.96 standard deviation (SD).
  measure: Postoperative need of supplemental oxygen
  time frame: During PACU/ICU stay after surgery (max. of first 24 hours after surgery)
  description: We will record postoperative need for administration of supplemental oxygen to maintain a SpO2 of 93% during PACU or ICU stay.
  measure: Length of stay in ICU
  time frame: First 30 days after surgery
  description: Length of stay in ICU after surgery.
  measure: Incidence of Postoperative nausea and vomiting in the early postoperative period
  time frame: First two hours after surgery
  description: Episode of nausea and/or vomiting within the first two hours after surgery
  measure: Incidence of Postoperative nausea and vomiting in the late postoperative period
  time frame: First five postoperative days
  description: Episode of nausea and/or vomiting from two hours after surgery until the fifth postoperative day.
  measure: Intraoperative hypotension
  time frame: During surgery
  description: Intraoperative duration of mean arterial pressure <65mmHg and overall amount of intraoperatively administered catecholamines (including phenylephrine, norepinephrine, epinephrine, etilefrine, ephedrine).
  measure: Death within 5 days after surgery
  time frame: First five postoperative days
  description: Mortality in the first five postoperative days.
  measure: Days at home in the first month after surgery
  time frame: First 30 days after surgery
  description: Number of days at home within the first 30 postoperative days.
  measure: Long-term postoperative cognitive dysfunction
  time frame: One year after surgery
  description: Long-term postoperative cognitive dysfunction will be assessed via Montreal cognitive assessment (MoCA). We will assess the baseline MoCA a day before surgery and one year after surgery via phone interview. Minimum score of the MoCA is 0 points. Maximum score of the MoCA is 22 points. Postoperative cognitive dysfunction is defined as a reduction of at least 2 points as compared to baseline.
  measure: Postoperative IL-6 concentrations (pg/ml)
  time frame: First two postoperative days
  description: Postoperative area under the curve (AUC) within the first two postoperative days of concentrations of Interleukin 6 (IL-6).
  measure: Postoperative PCT concentrations (ng/ml)
  time frame: First two postoperative days
  description: Postoperative area under the curve (AUC) within the first two postoperative days of concentrations of Procalcitonin (PCT).
  measure: Postoperative CRP concentrations (mg/dl)
  time frame: First two postoperative days
  description: Postoperative area under the curve (AUC) within the first two postoperative days of concentrations of C-reactive protein (CRP).
  measure: Postoperative Copeptin concentrations (pmol/L)
  time frame: First two postoperative days
  description: AUC within the first two postoperative days of concentrations of Copeptin.
  measure: Postoperative TnT concentrations (ng/L)
  time frame: First two postoperative days
  description: AUC within the first two postoperative days of concentrations of TnT.
  measure: Postoperative NT-proBNP concentrations (pg/ml)
  time frame: First two postoperative days
  description: AUC within the first two postoperative days of concentrations of NT-proBNP.
  measure: Postoperative S100-B concentrations (µg/L)
  time frame: First two postoperative days
  description: AUC within the first two postoperative days of concentrations of S100-B.
  measure: Postoperative NSE concentrations (µg/L)
  time frame: First two postoperative days
  description: AUC within the first two postoperative days of concentrations of NSE.
  measure: All-cause death within one year after surgery
  time frame: One year after surgery
  description: All cause one-year mortality.
  arm group label: Desflurane Group
  arm group type: Experimental
  description: After induction of anesthesia, maintenance of anesthesia will be performed using goal-directed administration of desflurane with an intraoperative goal of bispectral index (BIS) 50±10.
  arm group label: Sevoflurane Group
  arm group type: Active Comparator
  description: After induction of anesthesia, maintenance of anesthesia will be performed using goal-directed administration of sevoflurane with an intraoperative goal of bispectral index (BIS) 50±10.
  arm group label: Propofol Group
  arm group type: Active Comparator
  description: After induction of anesthesia, maintenance of anesthesia will be performed using goal-directed administration of propofol with an intraoperative goal of bispectral index (BIS) 50±10.
  intervention type: Drug
  intervention name: Desflurane
  description: After induction of anesthesia, maintenance of anesthesia will be performed using goal-directed administration of desflurane with an intraoperative goal of bispectral index (BIS) 50±10.
  arm group label: Desflurane Group
  intervention type: Drug
  intervention name: Sevoflurane
  description: After induction of anesthesia, maintenance of anesthesia will be performed using goal-directed administration of sevoflurane with an intraoperative goal of bispectral index (BIS) 50±10.
  arm group label: Sevoflurane Group
  intervention type: Drug
  intervention name: Propofol
  description: After induction of anesthesia, maintenance of anesthesia will be performed using goal-directed administration of propofol with an intraoperative goal of bispectral index (BIS) 50±10.
  arm group label: Propofol Group
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Christian Reiterer, Prof. MD
  role: Principal Investigator
  affiliation: Medical University of Vienna
  last name: Alexander Taschner, MD
  phone: 0043 1 40400
  phone ext: 20760
  email: alexander.taschner@meduniwien.ac.at
  facility: 
  status: Recruiting
  contact: 
  country: Austria
  responsible party type: Principal Investigator
  investigator affiliation: Medical University of Vienna
  investigator full name: Christian Reiterer
  investigator title: Principal Investigator
  mesh term: Delirium
  mesh term: Emergence Delirium
  mesh term: Postoperative Cognitive Complications
  mesh term: Cognitive Dysfunction
  mesh term: Propofol
  mesh term: Sevoflurane
  mesh term: Desflurane
  sharing ipd: No