Antiperistaltic Effect and Safety of Glycopyrronium for Colonoscopic Polypectomy

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06041984
• Other study ID #: 2023114
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• Start date: October 8, 2023
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: June 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonoscopy
• Glycopyrrolate

Intervention

Drug:
• Glycopyrrolate
Intravenous injection of glycopyrrolate 0.2mg

Other:
• Placebo
Intravenous injection of saline 1ml

Locations

Country	Name	City	State
China	The Second Affiliated Hospital Of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Jie Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During Colonoscopy
Secondary	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.	During Colonoscopy
Secondary	Polyp Treatment Time	Time from start of polyp removal to complete polyp removal.	During Colonoscopy