Colonoscopy, Glycopyrrolate
Conditions
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.
Interventions
DRUGGlycopyrrolate
Intravenous injection of glycopyrrolate 0.2mg
OTHERPlacebo
Intravenous injection of saline 1ml
Sponsors
Jie Chen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intestinal spasm | During Colonoscopy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| inhibitory effect score | During Colonoscopy | 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. |
| Polyp Treatment Time | During Colonoscopy | Time from start of polyp removal to complete polyp removal. |
Countries
China
Outcome results
None listed