Antiperistaltic Effect and Safety of Glycopyrronium for Colonoscopic Polypectomy

Jie Chen

Status and phase: Invitation-only; Phase 2; Phase 1

Conditions: Colonoscopy; Glycopyrrolate

Treatments: Other: Placebo; Drug: Glycopyrrolate

Study type: Interventional

Funder types: Other

Identifiers

NCT06041984

2023114

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups, including a placebo group

Glycopyrrolate

Experimental group

Description:

Participants will receive intravenous glycopyrrolate 0.2 mg while receiving anesthetic.

Treatment:

Drug: Glycopyrrolate

Placebo

Placebo Comparator group

Description:

Participants will receive intravenous 1ml saline while receiving anesthetic.

Treatment:

Other: Placebo