<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/NCT04477733</url>
  </required_header>
  <id_info>
    <org_study_id>wj20200710</org_study_id>
    <nct_id>NCT04477733</nct_id>
  </id_info>
  <brief_title>Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain</brief_title>
  <official_title>Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Tiantan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Tiantan Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The total incidence of abdominal pain after colonoscopy is almost 50%. Butorphanol is a mixed&#xD;
      opioid receptor agonist-antagonist, which has strong sedative and analgesic effects. This&#xD;
      clinical study aims to explore the effectiveness and safety of butorphanol combined with&#xD;
      propofol for colonoscopy to reduce postoperative visceral pain, and provide a basis for&#xD;
      improving the quality of surgery and comfortable medical treatment for patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2020</start_date>
  <completion_date type="Actual">September 30, 2021</completion_date>
  <primary_completion_date type="Actual">September 30, 2021</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>visceral pain</measure>
    <time_frame>10 minutes after recovery</time_frame>
    <description>VAS score of visceral pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>visceral pain at 20 and 30 minutes after recovery</measure>
    <time_frame>20 and 30 minutes after recovery</time_frame>
    <description>VAS score of visceral pain</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">203</enrollment>
  <condition>Colonoscopy</condition>
  <arm_group>
    <arm_group_label>Butorphanol group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Butorphanol Injection</intervention_name>
    <description>Inject 10 μg/kg of butorphanol, then propofol is injected until the patient's eyelash reflex disappears before performing colonoscopy</description>
    <arm_group_label>Butorphanol group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Inject saline and propofol until the patient's eyelash reflex disappears before performing colonoscopy</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA status I-11&#xD;
&#xD;
          -  patients performing colonoscopy&#xD;
&#xD;
          -  sign the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI&gt;30, pregnant&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  depression&#xD;
&#xD;
          -  patients dependent on opioids&#xD;
&#xD;
          -  hypertension poorly controlled&#xD;
&#xD;
          -  serious complications of important organs&#xD;
&#xD;
          -  obvious abdominal pain before colonoscopy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beijing Tiantan Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100070</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>February 18, 2022</last_update_submitted>
  <last_update_submitted_qc>February 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Tiantan Hospital</investigator_affiliation>
    <investigator_full_name>Ruquan Han</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>Butorphanol, Visceral pain, Propofol, Gastroscopy, Colonoscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Visceral Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Butorphanol</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/NCT04477733
org study id: wj20200710
nct id: NCT04477733
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The total incidence of abdominal pain after colonoscopy is almost 50%. Butorphanol is a mixed
      opioid receptor agonist-antagonist, which has strong sedative and analgesic effects. This
      clinical study aims to explore the effectiveness and safety of butorphanol combined with
      propofol for colonoscopy to reduce postoperative visceral pain, and provide a basis for
      improving the quality of surgery and comfortable medical treatment for patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: visceral pain
time frame: 10 minutes after recovery
description: VAS score of visceral pain
measure: visceral pain at 20 and 30 minutes after recovery
time frame: 20 and 30 minutes after recovery
description: VAS score of visceral pain
arm group label: Butorphanol group
arm group type: Experimental
arm group label: control group
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Butorphanol Injection
description: Inject 10 μg/kg of butorphanol, then propofol is injected until the patient's eyelash reflex disappears before performing colonoscopy
arm group label: Butorphanol group
intervention type: Drug
intervention name: Saline
description: Inject saline and propofol until the patient's eyelash reflex disappears before performing colonoscopy
arm group label: control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Tiantan Hospital
investigator full name: Ruquan Han
investigator title: professor
mesh term: Visceral Pain
mesh term: Butorphanol