Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain
1 other identifier
interventional
203
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2020
CompletedFirst Posted
Study publicly available on registry
July 20, 2020
CompletedStudy Start
First participant enrolled
August 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedFebruary 21, 2022
February 1, 2022
1.1 years
July 10, 2020
February 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
visceral pain
VAS score of visceral pain
10 minutes after recovery
Secondary Outcomes (1)
visceral pain at 20 and 30 minutes after recovery
20 and 30 minutes after recovery
Study Arms (2)
Butorphanol group
EXPERIMENTALcontrol group
PLACEBO COMPARATORInterventions
Inject 10 μg/kg of butorphanol, then propofol is injected until the patient's eyelash reflex disappears before performing colonoscopy
Inject saline and propofol until the patient's eyelash reflex disappears before performing colonoscopy
Eligibility Criteria
You may qualify if:
- ASA status I-11
- patients performing colonoscopy
- sign the informed consent
You may not qualify if:
- BMI\>30, pregnant
- diabetes
- depression
- patients dependent on opioids
- hypertension poorly controlled
- serious complications of important organs
- obvious abdominal pain before colonoscopy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Tiantan Hospital
Beijing, 100070, China
Related Publications (1)
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: 36977981DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
July 10, 2020
First Posted
July 20, 2020
Study Start
August 14, 2020
Primary Completion
September 30, 2021
Study Completion
September 30, 2021
Last Updated
February 21, 2022
Record last verified: 2022-02