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OpenTrials
Completed

NCT Number: NCT04477733

Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain

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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Key information

Conditions

Colonoscopy Neurologic Manifestations Nociceptive Pain Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Visceral Pain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Tiantan Hospital

Beijing, 100070, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. visceral pain

    Time frame: 10 minutes after recovery

    VAS score of visceral pain

Secondary outcomes

  1. visceral pain at 20 and 30 minutes after recovery

    Time frame: 20 and 30 minutes after recovery

    VAS score of visceral pain

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 20, 2020
Registry last updated
Feb 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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