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CompletedNCT04477733Updated Feb 21, 2022

Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain

A Phase 4 interventional study of Butorphanol Injection and Saline in Colonoscopy, sponsored by Beijing Tiantan Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-02-21.

Sponsored by Beijing Tiantan Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
203
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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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Conditions studied

  • Colonoscopy

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Keywords

  • Butorphanol, Visceral pain, Propofol, Gastroscopy, Colonoscopy
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In context

Visceral Pain

49 studies on the registry are indexed under Visceral Pain; 16 are open to participants now.

This study's enrollment of 203 is above the median of 72 across 45 interventional studies indexed under Visceral Pain.

Browse Visceral Pain studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 481 studies on the registry; 287 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ASA status I-11
  • patients performing colonoscopy
  • sign the informed consent

Exclusion criteria

Exclusion Criteria:

  • BMI>30, pregnant
  • diabetes
  • depression
  • patients dependent on opioids
  • hypertension poorly controlled
  • serious complications of important organs
  • obvious abdominal pain before colonoscopy
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
203 participants (actual)

Study arms

  • Experimental
    Butorphanol group

    Drug: Butorphanol Injection

  • Placebo comparator
    control group

    Drug: Saline

Interventions

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

  • DrugSaline

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

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What researchers measure

Primary outcomes

  1. visceral pain

    VAS score of visceral pain

    Time frame: 10 minutes after recovery

Secondary outcomes

  1. visceral pain at 20 and 30 minutes after recovery

    VAS score of visceral pain

    Time frame: 20 and 30 minutes after recovery

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Study locations

1 site
  • Beijing Tiantan Hospital
    Beijing, 100070, China
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References and documents

Publications

  • 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. PubMed 36977981 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04477733
Responsible party
Ruquan Han (professor, Beijing Tiantan Hospital) — Principal investigator
First posted
Jul 20, 2020
Start date
Aug 14, 2020
Primary completion
Sep 30, 2021
Completion
Sep 30, 2021
Last update
Feb 21, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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