Antiperistaltic Effect and Safety of Glycopyrronium for Colonoscopic Polypectomy

Phase 1

• Conditions: Glycopyrrolate; Colonoscopy
• Interventions: Drug: Glycopyrrolate; Other: Placebo

• Registration Number: NCT06041984
• Lead Sponsor: Jie Chen

Brief 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.

Study Timeline

• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-09-12
• Study First Posted: 2023-09-18
• Study Start: 2023-10-08
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-08
• Primary Completion: 2024-04
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Age 18-80 years old.
• Outpatients and inpatients with lesions to be resected under colonoscopy.
• Participants voluntarily participated and signed informed consent forms.

Exclusion Criteria

• Pregnancy status and lactating women.
• With glaucoma, myasthenia gravis, hyperthyroidism, chronic renal insufficiency, and inflammatory bowel disease.
• With obstructive gastrointestinal diseases such as pyloric obstruction, paralytic ileus, and achalasia of the cardia.
• With obstructive urinary tract diseases such as prostatic hyperplasia and dysuria.
• With heart disease such as arrhythmia (bradycardia, tachycardia, ventricular fibrillation, atrial fibrillation, etc.), coronary heart disease, congestive heart failure.
• With a history of previous abdominal or intestinal surgery.
• Anticholinergic drugs were administered 48 hours before surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glycopyrrolate	Glycopyrrolate	Participants will receive intravenous glycopyrrolate 0.2 mg while receiving anesthetic.
Placebo	Placebo	Participants will receive intravenous 1ml saline while receiving anesthetic.

Primary Outcome Measures

Name	Time	Method
Incidence of intestinal spasm	During Colonoscopy	The incidence of intestinal spasm in the two groups was calculated after determining whether colonic spasms occurred according to the inhibitory effect score.Rated on a scale of 1 to 3 according to the luminal opening diameter:1 (excellent): no spasm,lumen opening ≥ 2/3 of maximum diameter， 2 (fair): moderate spasm，lumen opening \< 2/3 of maximum diameter, but the oral side can be seen and 3 (poor): severe spasm，the oral side lumen is not visible.

Secondary Outcome Measures

Name	Time	Method
inhibitory effect score	During Colonoscopy	Rated on a scale of 1 to 3 according to the luminal opening diameter:1 (excellent): no spasm,lumen opening ≥ 2/3 of maximum diameter， 2 (fair): moderate spasm，lumen opening \< 2/3 of maximum diameter, but the oral side can be seen and 3 (poor): severe spasm，the oral side lumen is not visible.
Polyp Treatment Time	During Colonoscopy	Time from start of polyp removal to complete polyp removal.

Trial Locations

Locations (1)

The Second Affiliated Hospital Of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China