Antiperistaltic Effect and Safety of Glycopyrronium for Colonoscopic Polypectomy

Study Overview
=================
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.

Detailed 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.

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

Conditions
-----------------
Glycopyrrolate, Colonoscopy

Intervention / Treatment
-----------------
* Drug: Glycopyrrolate
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glycopyrrolate<br>Participants will receive intravenous glycopyrrolate 0.2 mg while receiving anesthetic. | Drug: Glycopyrrolate<br>* Intravenous injection of glycopyrrolate 0.2mg<br>|
| Placebo Comparator: Placebo<br>Participants will receive intravenous 1ml saline while receiving anesthetic. | Other: Placebo<br>* Intravenous injection of saline 1ml<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Polyp Treatment Time | Time from start of polyp removal to complete polyp removal. | During Colonoscopy |