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Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain

Primary Purpose

Colonoscopy

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Butorphanol Injection
Saline
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonoscopy focused on measuring Butorphanol, Visceral pain, Propofol, Gastroscopy, Colonoscopy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA status I-11
  • patients performing colonoscopy
  • sign the informed consent

Exclusion Criteria:

  • BMI>30, pregnant
  • diabetes
  • depression
  • patients dependent on opioids
  • hypertension poorly controlled
  • serious complications of important organs
  • obvious abdominal pain before colonoscopy

Sites / Locations

  • Beijing Tiantan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Butorphanol group

control group

Arm Description

Outcomes

Primary Outcome Measures

visceral pain
VAS score of visceral pain

Secondary Outcome Measures

visceral pain at 20 and 30 minutes after recovery
VAS score of visceral pain

Full Information

First Posted
July 10, 2020
Last Updated
February 18, 2022
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04477733
Brief Title
Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain
Official Title
Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 14, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonoscopy
Keywords
Butorphanol, Visceral pain, Propofol, Gastroscopy, Colonoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Butorphanol group
Arm Type
Experimental
Arm Title
control group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Butorphanol Injection
Intervention Description
Inject 10 μg/kg of butorphanol, then propofol is injected until the patient's eyelash reflex disappears before performing colonoscopy
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Inject saline and propofol until the patient's eyelash reflex disappears before performing colonoscopy
Primary Outcome Measure Information:
Title
visceral pain
Description
VAS score of visceral pain
Time Frame
10 minutes after recovery
Secondary Outcome Measure Information:
Title
visceral pain at 20 and 30 minutes after recovery
Description
VAS score of visceral pain
Time Frame
20 and 30 minutes after recovery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA status I-11 patients performing colonoscopy sign the informed consent Exclusion Criteria: BMI>30, pregnant diabetes depression patients dependent on opioids hypertension poorly controlled serious complications of important organs obvious abdominal pain before colonoscopy
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
ZIP/Postal Code
100070
Country
China

12. IPD Sharing Statement

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Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain

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