Antiperistaltic Effect and Safety of Glycopyrronium for Colonoscopic Polypectomy

NCT06041984 | Unknown Phase 1

• 1 other identifier: 2023114
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Glycopyrrolate; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• inhibitory effect score

  During Colonoscopy

• Polyp Treatment Time

  During Colonoscopy

Study Arms (2)

Glycopyrrolate

EXPERIMENTAL

Participants will receive intravenous glycopyrrolate 0.2 mg while receiving anesthetic.

Drug: Glycopyrrolate

Placebo

PLACEBO COMPARATOR

Participants will receive intravenous 1ml saline while receiving anesthetic.

Other: Placebo

Interventions

Glycopyrrolate DRUG

Intravenous injection of glycopyrrolate 0.2mg

Glycopyrrolate

Placebo OTHER

Intravenous injection of saline 1ml

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jie Chen: lead

Study Sites (1)

The Second Affiliated Hospital Of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

MeSH Terms

Interventions

Glycopyrrolate

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Guangyou Duan, doctor

  The Second Affiliated Hospital of Chongqing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 18, 2023
• Study Start: October 8, 2023
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)