Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain

NCT ID: NCT04477733

Last Updated: 2022-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-14

Study Completion Date

2021-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colonoscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Butorphanol group

Group Type EXPERIMENTAL

Butorphanol Injection

Intervention Type DRUG

Inject 10 μg/kg of butorphanol, then propofol is injected until the patient's eyelash reflex disappears before performing colonoscopy

control group

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Inject saline and propofol until the patient's eyelash reflex disappears before performing colonoscopy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Butorphanol Injection

Inject 10 μg/kg of butorphanol, then propofol is injected until the patient's eyelash reflex disappears before performing colonoscopy

Intervention Type DRUG

Saline

Inject saline and propofol until the patient's eyelash reflex disappears before performing colonoscopy

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ruquan Han

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Tiantan Hospital

Beijing, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 36977981 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

wj20200710

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.