Antiperistaltic Effect and Safety of Glycopyrronium for Colonoscopic Polypectomy

Phase 2UnknownNCT06041984

Jie Chen150 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

150

Conditions

Glycopyrrolate Colonoscopy

Interventions

GlycopyrrolateDRUG

Intravenous injection of glycopyrrolate 0.2mg

PlaceboOTHER

Intravenous injection of saline 1ml

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The Second Affiliated Hospital Of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Outcomes

Primary Outcomes

Incidence of intestinal spasm

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.

Time frame: During Colonoscopy

Secondary Outcomes

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.

Time frame: During Colonoscopy

Polyp Treatment Time

Time from start of polyp removal to complete polyp removal.

Time frame: During Colonoscopy

Data from ClinicalTrials.gov

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