MedDataX Logo

Antiperistaltic Effect and Safety of Glycopyrronium for Colonoscopic Polypectomy

NCT ID: NCT06041984

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE1/PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-08

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glycopyrrolate Colonoscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Glycopyrrolate

Participants will receive intravenous glycopyrrolate 0.2 mg while receiving anesthetic.

Group Type EXPERIMENTAL

Glycopyrrolate

Intervention Type DRUG

Intravenous injection of glycopyrrolate 0.2mg

Placebo

Participants will receive intravenous 1ml saline while receiving anesthetic.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Intravenous injection of saline 1ml

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Glycopyrrolate

Intravenous injection of glycopyrrolate 0.2mg

Intervention Type DRUG

Placebo

Intravenous injection of saline 1ml

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jie Chen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jie Chen

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Guangyou Duan, doctor

Role: STUDY_DIRECTOR

The Second Affiliated Hospital of Chongqing Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Second Affiliated Hospital Of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023114

Identifier Type: -

Identifier Source: org_study_id