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NCT04477733 Clinical Trial

Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain

Colonoscopy Clinical Trial

Official title:
Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04477733
Other study ID # wj20200710
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 14, 2020
Est. completion date September 30, 2021

Study information
Verified date February 2022
Source Beijing Tiantan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 203
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Butorphanol Injection
Inject 10 µg/kg of butorphanol, then propofol is injected until the patient's eyelash reflex disappears before performing colonoscopy
• Saline
Inject saline and propofol until the patient's eyelash reflex disappears before performing colonoscopy

Locations
Country Name City State
China Beijing Tiantan Hospital Beijing

Sponsors (1)
Lead Sponsor Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary visceral pain VAS score of visceral pain 10 minutes after recovery
Secondary visceral pain at 20 and 30 minutes after recovery VAS score of visceral pain 20 and 30 minutes after recovery
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