Effect of Butorphanol on Colonoscopy for Patients With Po... | NCT04477733

Studies
Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain

NCT04477733

Sponsor

Beijing Tiantan Hospital

Status

Completed

Last Update Posted

Feb 21, 2022Actual

Enrollment

203Actual

Phase

Phase 4

Conditions

Colonoscopy

Interventions

Butorphanol Injection
Saline

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 14, 2020Actual

Primary Completion Date

Sep 30, 2021Actual

Completion Date

Sep 30, 2021Actual

First Submitted Date

Jul 10, 2020

First Submission Date that Met QC Criteria

Jul 16, 2020

First Posted Date

Jul 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2022

Last Update Posted Date

Feb 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

203Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Butorphanol group	Experimental		Drug: Butorphanol Injection
control group	Placebo Comparator		Drug: Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Butorphanol Injection	Drug	Inject 10 μg/kg of butorphanol, then propofol is injected until the patient's eyelash reflex disappears before performing colonoscopy	Butorphanol group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
visceral pain	VAS score of visceral pain	10 minutes after recovery

Secondary Outcomes

Measure	Description	Time Frame
visceral pain at 20 and 30 minutes after recovery	VAS score of visceral pain	20 and 30 minutes after recovery

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Tiantan Hospital		Beijing		100070	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36977981	Derived	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.

ID	Term
D059226	Nociceptive Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

ID	Term
D002077	Butorphanol
D012965	Sodium Chloride

ID	Term
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds