Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain

NCT04477733 — Phase 4, Completed, 203 participants, Beijing Tiantan Hospital

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Registry	NCT04477733
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	203 (Actual)
Sponsor	Beijing Tiantan Hospital (Other)
Conditions	Colonoscopy
Interventions	Butorphanol Injection, Saline (Drug)
Dates	start 2020-08-14, primary completion 2021-09-30, completion 2021-09-30, first posted 2020-07-20, last updated 2022-02-21
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Butorphanol group	Experimental	Drug: Butorphanol Injection
control group	Placebo comparator	Drug: Saline

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

+Outcome measures

Primary outcomes

visceral pain [10 minutes after recovery]: VAS score of visceral pain

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
Beijing Tiantan Hospital	Beijing	China

+Publications

Results publication: Wang J, Wang X, Liu H, Han R. Effect of butorphanol on visceral pain in patients undergoing gastrointestinal endoscopy: a randomized controlled trial. BMC Anesthesiol. 2023 Mar 28;23(1):93. doi: 10.1186/s12871-023-02053-9. PMID 36977981

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