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/NCT05975385</url>
    </required_header>
    <id_info>
      <org_study_id>H-53767</org_study_id>
      <nct_id>NCT05975385</nct_id>
    </id_info>
    <brief_title>Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy</brief_title>
    <official_title>Acupuncture For Prevention Of Postoperative Nausea And Vomiting In Patients Undergoing Laparoscopic Cholecystectomy - A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Baylor College of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Baylor College of Medicine</source>
    <oversight_info>
      <has_dmc>No</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 purpose is to find out if intraoperative acupuncture performed by needling PC 6 and LI4&#xD;
        point bilaterally, and Yin Tang point will help reduce the incidence postoperative nausea and&#xD;
        vomiting in patients undergoing laparoscopic cholecystectomy when added to a prophylactic&#xD;
        regimen consisting of ondansetron and dexamethasone. The hypothesis is that the addition of&#xD;
        this acupuncture treatment to ondansetron and dexamethasone given for prophylaxis will help&#xD;
        reduce the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic&#xD;
        cholecystectomy when compared to patients receiving ondansetron and dexamethasone without&#xD;
        acupuncture.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2025</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>
      <intervention_model_description>Randomized controlled trial. Group 1 - Acupuncture Group 2 - No acupuncture</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>Patient will be under general anesthesia when treatment provided. They will not know whether or not they received acupuncture treatment. Postoperative assessors will not know which group the patient is in.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of postoperative nausea and vomiting</measure>
      <time_frame>Postoperative: 0-1 hours, 1-6 hours, 6-12 hours, 12-24 hours</time_frame>
      <description>Incidence of nausea and vomiting after surgery</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Postoperative pain</measure>
      <time_frame>24 hours</time_frame>
      <description>Pain on scale 1-10 measured on arrival to PACU, discharge from PACU and at 24 hours post surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total opioids used</measure>
      <time_frame>24 hours</time_frame>
      <description>Total opioid given, converted to oral morphine equivalents</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Cholecystitis, Acute</condition>
    <condition>Cholelithiasis</condition>
    <condition>Nausea, Postoperative</condition>
    <condition>Vomiting, Postoperative</condition>
    <condition>Pain, Postoperative</condition>
    <arm_group>
      <arm_group_label>Acupuncture</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group Acupuncture: Points PC 6 bilaterally, LI 4 bilaterally, and Yin Tang will be needled using Seirin L Type 0.25 X 40 mm needles. MH 6 is located 2 cun (a traditional Chinese unit of length) above the wrist crease in between the tendons of palmaris longus and flexor carpi radialis. LI 4 is in the middle of first and second metacarpal bones. Yin Tang is located between the eyebrows. All needles will be removed once skin closure begins, and before emergence and extubation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No acupuncture treatment provided</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Acupuncture</intervention_name>
      <description>Acupuncture at points points PC 6 bilaterally, LI 4 bilaterally, and Yin Tang</description>
      <arm_group_label>Acupuncture</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patient ages 18-64&#xD;
  &#xD;
            2. American Society of Anesthesiology Physical Status I, II or III&#xD;
  &#xD;
            3. Patients scheduled to undergo laparoscopic cholecystectomy at Harris Health System Ben&#xD;
               Taub Hospital&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Scheduled open cholecystectomy - excluded due to increased levels of pain in open&#xD;
               procedures&#xD;
  &#xD;
            2. Renal dysfunction (Serum Cr &gt; 1.2) - excluded due to potential altered metabolism of&#xD;
               anesthetic and perioperative medications&#xD;
  &#xD;
            3. Allergy to any of the standard anesthetic agents&#xD;
  &#xD;
            4. Patient inability to properly communicate with investigators (language barrier,&#xD;
               dementia, delirium, psychiatric disorder)&#xD;
  &#xD;
            5. Patient or surgeon refusal&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jaime Ortiz, MD, MBA</last_name>
      <phone>713-873-2860</phone>
      <email>jaimeo@bcm.edu</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
      <investigator_full_name>Jaime Ortiz</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>Cholecystitis</mesh_term>
      <mesh_term>Cholelithiasis</mesh_term>
      <mesh_term>Cholecystitis, Acute</mesh_term>
      <mesh_term>Nausea</mesh_term>
      <mesh_term>Vomiting</mesh_term>
      <mesh_term>Pain, Postoperative</mesh_term>
      <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
    </condition_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/NCT05975385
  org study id: H-53767
  nct id: NCT05975385
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose is to find out if intraoperative acupuncture performed by needling PC 6 and LI4
        point bilaterally, and Yin Tang point will help reduce the incidence postoperative nausea and
        vomiting in patients undergoing laparoscopic cholecystectomy when added to a prophylactic
        regimen consisting of ondansetron and dexamethasone. The hypothesis is that the addition of
        this acupuncture treatment to ondansetron and dexamethasone given for prophylaxis will help
        reduce the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic
        cholecystectomy when compared to patients receiving ondansetron and dexamethasone without
        acupuncture.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized controlled trial. Group 1 - Acupuncture Group 2 - No acupuncture
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: Patient will be under general anesthesia when treatment provided. They will not know whether or not they received acupuncture treatment. Postoperative assessors will not know which group the patient is in.
  measure: Incidence of postoperative nausea and vomiting
  time frame: Postoperative: 0-1 hours, 1-6 hours, 6-12 hours, 12-24 hours
  description: Incidence of nausea and vomiting after surgery
  measure: Postoperative pain
  time frame: 24 hours
  description: Pain on scale 1-10 measured on arrival to PACU, discharge from PACU and at 24 hours post surgery
  measure: Total opioids used
  time frame: 24 hours
  description: Total opioid given, converted to oral morphine equivalents
  arm group label: Acupuncture
  arm group type: Experimental
  description: Group Acupuncture: Points PC 6 bilaterally, LI 4 bilaterally, and Yin Tang will be needled using Seirin L Type 0.25 X 40 mm needles. MH 6 is located 2 cun (a traditional Chinese unit of length) above the wrist crease in between the tendons of palmaris longus and flexor carpi radialis. LI 4 is in the middle of first and second metacarpal bones. Yin Tang is located between the eyebrows. All needles will be removed once skin closure begins, and before emergence and extubation.
  arm group label: Control
  arm group type: No Intervention
  description: No acupuncture treatment provided
  intervention type: Procedure
  intervention name: Acupuncture
  description: Acupuncture at points points PC 6 bilaterally, LI 4 bilaterally, and Yin Tang
  arm group label: Acupuncture
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 64 Years
  healthy volunteers: No
  last name: Jaime Ortiz, MD, MBA
  phone: 713-873-2860
  email: jaimeo@bcm.edu
  responsible party type: Principal Investigator
  investigator affiliation: Baylor College of Medicine
  investigator full name: Jaime Ortiz
  investigator title: Professor of Anesthesiology
  mesh term: Cholecystitis
  mesh term: Cholelithiasis
  mesh term: Cholecystitis, Acute
  mesh term: Nausea
  mesh term: Vomiting
  mesh term: Pain, Postoperative
  mesh term: Postoperative Nausea and Vomiting
  sharing ipd: No