NCT06041984

Antiperistaltic Effect and Safety of Glycopyrronium for Colonoscopic Polypectomy

Antiperistaltic Effect and Safety of Glycopyrronium for Colonoscopic Polypectomy: a Randomized, Double-blind, Placebo-controlled Study

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Jie Chen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the antiperistaltic effect and safety of glycopyrrolate and whether the use of glycopyrrolate is beneficial for colonoscopy and colonoscopic polypectomy.

Detailed description

Colonic spasm is a major adverse event affecting colonoscopy.The current mainstay for the prevention of colonic spasm is the use of antispasmodic.Glycopyrrolate is a long-acting quaternary ammonium anticholinergic drug.The study is designed as a randomized, double-blind, placebo-controlled study of the efficacy and safety of glycopyrrolate in participants receiving colonoscopy and colonoscopic polypectomy. Patients at our center who met the inclusion criteria were randomized into the glycopyrrolate group and the placebo group, and then statistically analyzed whether there was any difference in the incidence of spasticity, spasticity scores, polyp treatment time, and satisfaction with endoscopist operation between the two groups.

Conditions

• Glycopyrrolate
• Colonoscopy

Interventions

Type	Name	Description
DRUG	Glycopyrrolate	Intravenous injection of glycopyrrolate 0.2mg
OTHER	Placebo	Intravenous injection of saline 1ml

Timeline

• Start date: 2023-10-08
• Primary completion: 2024-04-01
• Completion: 2024-06-01
• First posted: 2023-09-18
• Last updated: 2023-12-08

Locations

1 site across 1 country: China