<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/NCT02234466</url>
  </required_header>
  <id_info>
    <org_study_id>B2014:004</org_study_id>
    <nct_id>NCT02234466</nct_id>
  </id_info>
  <brief_title>Preoperative Oral Dexamethasone to Improve Recovery After Surgery</brief_title>
  <official_title>The Use of Preoperative Oral Dexamethasone to Improve Quality of Recovery After Breast Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Manitoba</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized controlled trial of pre-operative oral dexamethasone vs placebo for the&#xD;
      improvement of quality of recovery from surgery. The study population is limited to breast&#xD;
      surgery patients. The investigators will also look at the effect of our intervention on post&#xD;
      operative nausea and vomiting.&#xD;
&#xD;
      Patients will be recruited before the date of their surgery and will complete the Quality of&#xD;
      Recovery-40 (QOR-40) questionnaire before their surgery and at 24 hours post op. They will&#xD;
      also complete a Clinically significant nausea and vomiting score upon discharge from the post&#xD;
      anesthesia recovery room, repeated at 24 hours post op.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design: This will be a single centre randomized, double blind, parallel-group, intention to&#xD;
      treat, controlled trial. Patients are randomly assigned to pre-operative oral dexamethasone&#xD;
      or placebo&#xD;
&#xD;
      Group 1: Pre-operative oral dexamethasone (10mg-2 hours pre-induction) Group 2: Placebo&#xD;
      Sample Size: 80 patients (80% power to detect a difference of 10 points in our primary&#xD;
      endpoint)&#xD;
&#xD;
      Study duration: 8 months&#xD;
&#xD;
      Primary endpoint: Quality of recovery at 24 hours post operation, as measured on the QoR-40&#xD;
      Secondary endpoints: Clinically significant nausea and vomiting on discharge from&#xD;
      Post-Anesthesia Recovery Room (PARR) and at 24 hours.&#xD;
&#xD;
      Study hypotheses:Pre-operative oral dexamethasone will improve patient quality of recovery&#xD;
      compared to placebo.&#xD;
&#xD;
      Secondary hypothesis: Pre-operative dexamethasone will decrease clinically significant post&#xD;
      operative nausea and vomiting in the post anesthesia recovery room and this benefit will&#xD;
      endure at 24 hours.&#xD;
&#xD;
      Importance: Small studies in other adult populations suggest that IV dexamethasone may&#xD;
      improve quality of recovery. IV dexamethasone is widely used off label for postoperative&#xD;
      nausea and vomiting (PONV) prophylaxis, oral dexamethasone has not been studied for this&#xD;
      indication but based on the pharmacodynamics of dexamethasone, and that modulation of&#xD;
      nucleolar transcription is likely important in dexamethasone's clinical effect; an earlier&#xD;
      administration time is likely of benefit, this could be facilitated by an oral (vs IV) route&#xD;
      of administration. This study will provide the preliminary support (or absence of support)&#xD;
      for a routine, inexpensive intervention to optimize patient outcome.&#xD;
&#xD;
      Background: Single, low dose perioperative dexamethasone is safe and beneficial but common&#xD;
      timing of administration does not maximize effectiveness. IV dexamethasone improves quality&#xD;
      of recovery in patients undergoing laparoscopic cholecystectomy and provides a potential 1.5&#xD;
      mm improvement in VAS pain scores in the first 6 hours post mastectomy, which is of&#xD;
      questionable clinical significance. A study to determine if dexamethasone improves the&#xD;
      quality of recovery in patients undergoing breast surgery is needed in order to provide&#xD;
      evidence for change of practices and pre-operative oral dexamethasone offers the potential&#xD;
      for routine, low cost administration without uncomfortable side effects.&#xD;
&#xD;
      Methods: Patients will be recruited pre-operatively and contacted by telephone for&#xD;
      preliminary consent. They will receive consent documents on the morning of surgery and be&#xD;
      randomized at that time, they will complete a pre-operative QOR-40 and receive oral&#xD;
      dexamethasone or placebo. During their general anaesthesia (GA) they will all receive IV&#xD;
      Ondansetron and have their blood glucose measured 2 hours after skin incision. On discharge&#xD;
      from PARR they will have a clinically significant nausea and vomiting scale score recorded,&#xD;
      repeated at 24 hours post op. They will also complete the QOR-40 at 24 hours post op.&#xD;
&#xD;
      Analysis: Data will be analyzed using analysis of variance, mixed models and t-tests.&#xD;
&#xD;
      Potential Pitfalls: As the QOR-40 instrument is a survey, it is prone to inter and intra&#xD;
      patient variability. The investigators are controlling for inter-patient variability by&#xD;
      having patients complete the instrument before surgery to collect an individual baseline. The&#xD;
      investigators are relying on a 25% recruitment rate of eligible patients in order to complete&#xD;
      the study in the stated timeframe. The study has an important but narrow focus, it is not&#xD;
      feasible to perform subgroup analysis on the small study size.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">June 2015</completion_date>
  <primary_completion_date type="Anticipated">March 2015</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Quality of recovery at Post operative day 1 (POD1)</measure>
    <time_frame>24 hours</time_frame>
    <description>Quality of recovery as assessed by the QOR-40 will be assessed at POD1, with a baseline measure having been collected immediately pre-operatively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post operative Nausea and Vomiting immediately post operatively</measure>
    <time_frame>At discharge from Post Anesthesia Recovery Room, usually within 90 mins to 180 mins after surgery</time_frame>
    <description>Assayed by the Clinically Significant Nausea and Vomiting Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post operative Nausea and Vomiting in first 24 hours</measure>
    <time_frame>The first 24 hours after surgery</time_frame>
    <description>Post operative Nausea and Vomiting as assessed by the Clinically Significant Nausea and Vomiting scale on POD1, assessing the period from surgery until the assessment (not excluding post anesthesia recovery room)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Oral Dexamethasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral dexamethasone- two 4mg tabs and one 2mg tab contained within a gelatin capsule Administered a single time, 2 hours pre-induction&#xD;
Ondansetron 6mg IV will be administered at skin closure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gelatin pill</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Gelatin capsule contained within second gelatin capsule. Administered a single time, 2 hours pre-induction&#xD;
Ondansetron 6mg IV will be administered at skin closure</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral dexamethasone</intervention_name>
    <description>Patients will received their study drug ( or placebo) 2 hours pre-induction. Allowing for the shifting schedules of the OR with the possibility of the previous case finishing early or late, the allowable range is 90-200 minutes pre-induction.</description>
    <arm_group_label>Oral Dexamethasone</arm_group_label>
    <other_name>Decadron</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ondansetron</intervention_name>
    <description>Patients in both groups will receive 6mg IV ondansetron at time of skin closure as their standardized prophylaxis for postoperative nausea and vomiting.</description>
    <arm_group_label>Gelatin pill</arm_group_label>
    <arm_group_label>Oral Dexamethasone</arm_group_label>
    <other_name>Zofran</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gelatin capsule</intervention_name>
    <description>Gelatin capsule enclosing either dexamethasone tabs or second gelatin capsule</description>
    <arm_group_label>Gelatin pill</arm_group_label>
    <arm_group_label>Oral Dexamethasone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (18 to 80 years of age) undergoing general anesthesia for elective breast&#xD;
             surgery (lumpectomy or mastectomy) and providing informed consent.&#xD;
&#xD;
          -  American Society of Anesthesia (ASA) class I, II, &amp; III patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA class IV and V patients&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  History of allergy to any study medications&#xD;
&#xD;
          -  Use of steroids or anti emetics within 1 month of surgery&#xD;
&#xD;
          -  Chronic pain requiring opioid treatment&#xD;
&#xD;
          -  History of alcohol or drug abuse (including smoking tobacco)&#xD;
&#xD;
          -  Severe renal impairment (i.e. serum creatinine more than 160 umol/L)&#xD;
&#xD;
          -  Poor English comprehension or psychiatric/central nervous system disturbance that&#xD;
             would preclude completion of the QoR-40 questionnaire&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Faisal Siddiqui, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Health Science Centre</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3A 1R9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 31, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>September 8, 2014</last_update_submitted>
  <last_update_submitted_qc>September 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manitoba</investigator_affiliation>
    <investigator_full_name>Dr. Faisal Siddiqui</investigator_full_name>
    <investigator_title>Dr. Faisal Siddiqui, MD FRCPC</investigator_title>
  </responsible_party>
  <keyword>Quality of Recovery (QOR40)</keyword>
  <keyword>Breast Surgery</keyword>
  <keyword>Clinically significant Nausea and Vomiting</keyword>
  <keyword>Postoperative Nausea and Vomiting</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Ondansetron</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02234466
org study id: B2014:004
nct id: NCT02234466
lead sponsor: 
has dmc: No
Randomized controlled trial of pre-operative oral dexamethasone vs placebo for the
      improvement of quality of recovery from surgery. The study population is limited to breast
      surgery patients. The investigators will also look at the effect of our intervention on post
      operative nausea and vomiting.

      Patients will be recruited before the date of their surgery and will complete the Quality of
      Recovery-40 (QOR-40) questionnaire before their surgery and at 24 hours post op. They will
      also complete a Clinically significant nausea and vomiting score upon discharge from the post
      anesthesia recovery room, repeated at 24 hours post op.
Design: This will be a single centre randomized, double blind, parallel-group, intention to
      treat, controlled trial. Patients are randomly assigned to pre-operative oral dexamethasone
      or placebo

      Group 1: Pre-operative oral dexamethasone (10mg-2 hours pre-induction) Group 2: Placebo
      Sample Size: 80 patients (80% power to detect a difference of 10 points in our primary
      endpoint)

      Study duration: 8 months

      Primary endpoint: Quality of recovery at 24 hours post operation, as measured on the QoR-40
      Secondary endpoints: Clinically significant nausea and vomiting on discharge from
      Post-Anesthesia Recovery Room (PARR) and at 24 hours.

      Study hypotheses:Pre-operative oral dexamethasone will improve patient quality of recovery
      compared to placebo.

      Secondary hypothesis: Pre-operative dexamethasone will decrease clinically significant post
      operative nausea and vomiting in the post anesthesia recovery room and this benefit will
      endure at 24 hours.

      Importance: Small studies in other adult populations suggest that IV dexamethasone may
      improve quality of recovery. IV dexamethasone is widely used off label for postoperative
      nausea and vomiting (PONV) prophylaxis, oral dexamethasone has not been studied for this
      indication but based on the pharmacodynamics of dexamethasone, and that modulation of
      nucleolar transcription is likely important in dexamethasone's clinical effect; an earlier
      administration time is likely of benefit, this could be facilitated by an oral (vs IV) route
      of administration. This study will provide the preliminary support (or absence of support)
      for a routine, inexpensive intervention to optimize patient outcome.

      Background: Single, low dose perioperative dexamethasone is safe and beneficial but common
      timing of administration does not maximize effectiveness. IV dexamethasone improves quality
      of recovery in patients undergoing laparoscopic cholecystectomy and provides a potential 1.5
      mm improvement in VAS pain scores in the first 6 hours post mastectomy, which is of
      questionable clinical significance. A study to determine if dexamethasone improves the
      quality of recovery in patients undergoing breast surgery is needed in order to provide
      evidence for change of practices and pre-operative oral dexamethasone offers the potential
      for routine, low cost administration without uncomfortable side effects.

      Methods: Patients will be recruited pre-operatively and contacted by telephone for
      preliminary consent. They will receive consent documents on the morning of surgery and be
      randomized at that time, they will complete a pre-operative QOR-40 and receive oral
      dexamethasone or placebo. During their general anaesthesia (GA) they will all receive IV
      Ondansetron and have their blood glucose measured 2 hours after skin incision. On discharge
      from PARR they will have a clinically significant nausea and vomiting scale score recorded,
      repeated at 24 hours post op. They will also complete the QOR-40 at 24 hours post op.

      Analysis: Data will be analyzed using analysis of variance, mixed models and t-tests.

      Potential Pitfalls: As the QOR-40 instrument is a survey, it is prone to inter and intra
      patient variability. The investigators are controlling for inter-patient variability by
      having patients complete the instrument before surgery to collect an individual baseline. The
      investigators are relying on a 25% recruitment rate of eligible patients in order to complete
      the study in the stated timeframe. The study has an important but narrow focus, it is not
      feasible to perform subgroup analysis on the small study size.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline in Quality of recovery at Post operative day 1 (POD1)
time frame: 24 hours
description: Quality of recovery as assessed by the QOR-40 will be assessed at POD1, with a baseline measure having been collected immediately pre-operatively.
measure: Post operative Nausea and Vomiting immediately post operatively
time frame: At discharge from Post Anesthesia Recovery Room, usually within 90 mins to 180 mins after surgery
description: Assayed by the Clinically Significant Nausea and Vomiting Scale
measure: Post operative Nausea and Vomiting in first 24 hours
time frame: The first 24 hours after surgery
description: Post operative Nausea and Vomiting as assessed by the Clinically Significant Nausea and Vomiting scale on POD1, assessing the period from surgery until the assessment (not excluding post anesthesia recovery room)
arm group label: Oral Dexamethasone
arm group type: Active Comparator
description: Oral dexamethasone- two 4mg tabs and one 2mg tab contained within a gelatin capsule Administered a single time, 2 hours pre-induction
Ondansetron 6mg IV will be administered at skin closure
arm group label: Gelatin pill
arm group type: Placebo Comparator
description: Gelatin capsule contained within second gelatin capsule. Administered a single time, 2 hours pre-induction
Ondansetron 6mg IV will be administered at skin closure
intervention type: Drug
intervention name: Oral dexamethasone
description: Patients will received their study drug ( or placebo) 2 hours pre-induction. Allowing for the shifting schedules of the OR with the possibility of the previous case finishing early or late, the allowable range is 90-200 minutes pre-induction.
arm group label: Oral Dexamethasone
other name: Decadron
intervention type: Drug
intervention name: Ondansetron
description: Patients in both groups will receive 6mg IV ondansetron at time of skin closure as their standardized prophylaxis for postoperative nausea and vomiting.
arm group label: Gelatin pill
arm group label: Oral Dexamethasone
other name: Zofran
intervention type: Other
intervention name: Gelatin capsule
description: Gelatin capsule enclosing either dexamethasone tabs or second gelatin capsule
arm group label: Gelatin pill
arm group label: Oral Dexamethasone
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Faisal Siddiqui, MD
role: Principal Investigator
affiliation: University of Manitoba
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Manitoba
investigator full name: Dr. Faisal Siddiqui
investigator title: Dr. Faisal Siddiqui, MD FRCPC
mesh term: Dexamethasone
mesh term: Ondansetron