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/NCT05998317</url>
    </required_header>
    <id_info>
      <org_study_id>R.23.07.2239</org_study_id>
      <nct_id>NCT05998317</nct_id>
    </id_info>
    <brief_title>Dexamethasone at Night vs at Induction on PONV After Laparoscopic Cholecystectomy</brief_title>
    <official_title>Dexamethasone At-induction vs At-night to Prevent Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Protocol for Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mansoura University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mansoura University</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>
        Since the peak effect of the dexamethasone is delayed to 12-16 hours after iv administration,&#xD;
        we designed this study to investigate the effect of administering dexamethasone at-night&#xD;
        before surgery versus at-induction (the standard timing) in prevention of postoperative&#xD;
        nausea and vomiting after laparoscopic cholecystectomy.&#xD;
  &#xD;
        We will start a pilot randomized controlled study to explore the potential difference, ensure&#xD;
        correct and rigorous data collection, and calculate the sample size for a larger pragmatic&#xD;
        trial.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background:&#xD;
  &#xD;
        Postoperative nausea and vomiting (PONV) are common complications after laparoscopic&#xD;
        cholecystectomy. The aim of this study is to evaluate the efficacy of administration of&#xD;
        prophylactic dexamethasone 12-hours prior to induction of anesthesia in preventing PONV after&#xD;
        elective laparoscopic cholecystectomy, as it reaches its peak effect at 2-12 hours and lasts&#xD;
        for 72 hours after intravenous (iv) administration.&#xD;
  &#xD;
        Methods:&#xD;
  &#xD;
        We will perform a parallel two-arm, randomized (1:1), double-blind, controlled, single-center&#xD;
        trial. Adults (≥18 years) with American Society of Anesthesiology (ASA) physical status I-III&#xD;
        scheduled for elective laparoscopic cholecystectomy will be eligible for inclusion. The&#xD;
        participants will be randomized to receive either 8 mg IV Dexamethasone at time of induction&#xD;
        of anesthesia or 8 mg IV Dexamethasone at 12 hours prior to induction of anesthesia. The&#xD;
        primary outcome will be the incidence of postoperative nausea and vomiting. A total of 60&#xD;
        patients will be recruited as a pilot study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2023</primary_completion_date>
    <phase>Phase 2/Phase 3</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>
      <intervention_model_description>This is a randomized controlled trial superiority parallel trial. This is a pilot trial and the sample size will be updated after the pilot study completion and the approval of the local Institutional Review Board (IRB).</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
      <masking_description>The pharmacists will prepare the study drug, either dexamethasone or saline in 10 mL similar syringes, according to the allocation. The syringe will be labeled with the patient's name and the allocation group, A or B. The study participants, caregivers, data collectors, and data analysts will all be blinded. The pharmacists will not participate in the study.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>postoperative nausea or vomiting (PONV)</measure>
      <time_frame>24 hours after surgery</time_frame>
      <description>incidence of PONV (binary outcome as yes/No)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The need for rescue antiemetic</measure>
      <time_frame>24 hours after surgery</time_frame>
      <description>Dichotomous yes/no outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The need for rescue analgesia</measure>
      <time_frame>24 hours after surgery</time_frame>
      <description>Dichotomous yes/no outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative Care Unit (PACU) and Early PONV</measure>
      <time_frame>within 6 hours after surgery</time_frame>
      <description>Dichotomous yes/no outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Late PONV</measure>
      <time_frame>6-24 hours after surgery</time_frame>
      <description>Dichotomous yes/no outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual Analogue Scale (VAS)</measure>
      <time_frame>at the time of discharge from PACU (usually at 2 hours after surgery)</time_frame>
      <description>VAS as a scale 0 - 10</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual Analogue Scale (VAS)</measure>
      <time_frame>at the time of discharge from hospital (usually 24 hours after surgery)</time_frame>
      <description>VAS as a scale 0 - 10</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative quality of recovery (QoR)</measure>
      <time_frame>24 hours after surgery</time_frame>
      <description>QoR-15 questionnaire (doi: https://doi.org/10.1097/ALN.0b013e318289b84b)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post-Discharge Nausea and Vomiting (PDNV)</measure>
      <time_frame>at 72 hours after surgery</time_frame>
      <description>evaluated by telephone by Dichotomous yes/no outcome</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Surgical Site Infection</measure>
      <time_frame>at follow-up (usually at 7 days after surgery)</time_frame>
      <description>infection as defined by the surgeon) at the trocar's or the drainage tube sites.</description>
    </other_outcome>
    <other_outcome>
      <measure>Itching or burning sensation</measure>
      <time_frame>during injection of the dexamethasone</time_frame>
      <description>as described by the patient as dichotomous outcome yes/no outcome</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Postoperative Nausea and Vomiting</condition>
    <condition>Postoperative Pain</condition>
    <condition>Laparoscopic Cholecystectomy</condition>
    <arm_group>
      <arm_group_label>At-night dexamethasone</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in the intervention group will receive intravenous 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensation in injection.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>At-induction dexamethasone</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients in the control group will receive intravenous 8 mg dexamethasone just before or at the induction of anesthesia. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensation in injection.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>At-night Dexamethasone</intervention_name>
      <description>Patients in the intervention group will receive intravenous 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensation in injection.</description>
      <arm_group_label>At-night dexamethasone</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>At-induction Dexamethasone</intervention_name>
      <description>Patients in the control group will receive intravenous 8 mg dexamethasone just before or at the induction of anesthesia. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensation in injection.</description>
      <arm_group_label>At-induction dexamethasone</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  all consecutive adults (older than 18 years) with ASA physical status I-III undergoing&#xD;
               elective laparoscopic cholecystectomy surgery at gastrointestinal surgery center.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patient refusal&#xD;
  &#xD;
            -  use of steroids or antiemetic agents within 1 week of surgery&#xD;
  &#xD;
            -  chronic opioid therapy&#xD;
  &#xD;
            -  history of allergy to any study medications&#xD;
  &#xD;
            -  serum creatinine &gt; 1.4 mg/dl&#xD;
  &#xD;
            -  liver enzymes more than triple normal limits&#xD;
  &#xD;
            -  pregnancy&#xD;
  &#xD;
            -  psychiatric or neurologic diseases or socioeconomic status that would hinder&#xD;
               postoperative quality of recovery questionnaire&#xD;
  &#xD;
            -  Patients whose laparoscopic surgery is converted to open surgery after enrollment will&#xD;
               be excluded.&#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>Moataz M Emara, MD, EDAIC</last_name>
      <role>Study Chair</role>
      <affiliation>Mansoura University Faculty of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Moataz M Emara, MD, EDAIC</last_name>
      <phone>1064048848</phone>
      <phone_ext>+20</phone_ext>
      <email>mm.emara@mans.edu.eg</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Nausea</mesh_term>
      <mesh_term>Vomiting</mesh_term>
      <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexamethasone</mesh_term>
      <mesh_term>Dexamethasone acetate</mesh_term>
      <mesh_term>BB 1101</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The anonymised data will be available on appropriate response with the prinicipal investigator.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Within one year of study completion</ipd_time_frame>
      <ipd_access_criteria>will be notified shortly</ipd_access_criteria>
    </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/NCT05998317
  org study id: R.23.07.2239
  nct id: NCT05998317
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Since the peak effect of the dexamethasone is delayed to 12-16 hours after iv administration,
        we designed this study to investigate the effect of administering dexamethasone at-night
        before surgery versus at-induction (the standard timing) in prevention of postoperative
        nausea and vomiting after laparoscopic cholecystectomy.
  
        We will start a pilot randomized controlled study to explore the potential difference, ensure
        correct and rigorous data collection, and calculate the sample size for a larger pragmatic
        trial.
  Background:
  
        Postoperative nausea and vomiting (PONV) are common complications after laparoscopic
        cholecystectomy. The aim of this study is to evaluate the efficacy of administration of
        prophylactic dexamethasone 12-hours prior to induction of anesthesia in preventing PONV after
        elective laparoscopic cholecystectomy, as it reaches its peak effect at 2-12 hours and lasts
        for 72 hours after intravenous (iv) administration.
  
        Methods:
  
        We will perform a parallel two-arm, randomized (1:1), double-blind, controlled, single-center
        trial. Adults (≥18 years) with American Society of Anesthesiology (ASA) physical status I-III
        scheduled for elective laparoscopic cholecystectomy will be eligible for inclusion. The
        participants will be randomized to receive either 8 mg IV Dexamethasone at time of induction
        of anesthesia or 8 mg IV Dexamethasone at 12 hours prior to induction of anesthesia. The
        primary outcome will be the incidence of postoperative nausea and vomiting. A total of 60
        patients will be recruited as a pilot study.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is a randomized controlled trial superiority parallel trial. This is a pilot trial and the sample size will be updated after the pilot study completion and the approval of the local Institutional Review Board (IRB).
  primary purpose: Prevention
  masking: Triple (Participant, Care Provider, Investigator)
  masking description: The pharmacists will prepare the study drug, either dexamethasone or saline in 10 mL similar syringes, according to the allocation. The syringe will be labeled with the patient's name and the allocation group, A or B. The study participants, caregivers, data collectors, and data analysts will all be blinded. The pharmacists will not participate in the study.
  measure: postoperative nausea or vomiting (PONV)
  time frame: 24 hours after surgery
  description: incidence of PONV (binary outcome as yes/No)
  measure: The need for rescue antiemetic
  time frame: 24 hours after surgery
  description: Dichotomous yes/no outcome
  measure: The need for rescue analgesia
  time frame: 24 hours after surgery
  description: Dichotomous yes/no outcome
  measure: Postoperative Care Unit (PACU) and Early PONV
  time frame: within 6 hours after surgery
  description: Dichotomous yes/no outcome
  measure: Late PONV
  time frame: 6-24 hours after surgery
  description: Dichotomous yes/no outcome
  measure: Visual Analogue Scale (VAS)
  time frame: at the time of discharge from PACU (usually at 2 hours after surgery)
  description: VAS as a scale 0 - 10
  measure: Visual Analogue Scale (VAS)
  time frame: at the time of discharge from hospital (usually 24 hours after surgery)
  description: VAS as a scale 0 - 10
  measure: Postoperative quality of recovery (QoR)
  time frame: 24 hours after surgery
  description: QoR-15 questionnaire (doi: https://doi.org/10.1097/ALN.0b013e318289b84b)
  measure: Post-Discharge Nausea and Vomiting (PDNV)
  time frame: at 72 hours after surgery
  description: evaluated by telephone by Dichotomous yes/no outcome
  measure: Surgical Site Infection
  time frame: at follow-up (usually at 7 days after surgery)
  description: infection as defined by the surgeon) at the trocar's or the drainage tube sites.
  measure: Itching or burning sensation
  time frame: during injection of the dexamethasone
  description: as described by the patient as dichotomous outcome yes/no outcome
  arm group label: At-night dexamethasone
  arm group type: Experimental
  description: Patients in the intervention group will receive intravenous 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensation in injection.
  arm group label: At-induction dexamethasone
  arm group type: Active Comparator
  description: Patients in the control group will receive intravenous 8 mg dexamethasone just before or at the induction of anesthesia. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensation in injection.
  intervention type: Drug
  intervention name: At-night Dexamethasone
  description: Patients in the intervention group will receive intravenous 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensation in injection.
  arm group label: At-night dexamethasone
  intervention type: Drug
  intervention name: At-induction Dexamethasone
  description: Patients in the control group will receive intravenous 8 mg dexamethasone just before or at the induction of anesthesia. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensation in injection.
  arm group label: At-induction dexamethasone
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Moataz M Emara, MD, EDAIC
  role: Study Chair
  affiliation: Mansoura University Faculty of Medicine
  last name: Moataz M Emara, MD, EDAIC
  phone: 1064048848
  phone ext: +20
  email: mm.emara@mans.edu.eg
  responsible party type: Sponsor
  mesh term: Nausea
  mesh term: Vomiting
  mesh term: Postoperative Nausea and Vomiting
  mesh term: Dexamethasone
  mesh term: Dexamethasone acetate
  mesh term: BB 1101
  sharing ipd: Yes
  ipd description: The anonymised data will be available on appropriate response with the prinicipal investigator.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: Within one year of study completion
  ipd access criteria: will be notified shortly