Antiperistaltic Effect and Safety of Glycopyrronium for Colonoscopic Polypectomy: a Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Incidence of intestinal spasm
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-80 years old.
- •Outpatients and inpatients with lesions to be resected under colonoscopy.
- •Participants voluntarily participated and signed informed consent forms.
排除标准
- •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.
研究组 & 干预措施
Glycopyrrolate
Participants will receive intravenous glycopyrrolate 0.2 mg while receiving anesthetic.
干预措施: Glycopyrrolate (Drug)
Placebo
Participants will receive intravenous 1ml saline while receiving anesthetic.
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of intestinal spasm
时间窗: 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.
次要结局
- inhibitory effect score(During Colonoscopy)
- Polyp Treatment Time(During Colonoscopy)
研究者
Jie Chen
Clinical Professor
The Second Affiliated Hospital of Chongqing Medical University