Effect of Glycopyrrolate on Nausea and Vomiting After ERCP Operation
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Incidence of postoperative nausea and vomiting
研究概览
简要总结
This study aims to determine the role of Glycopyrrolate in preventing postoperative nausea and vomiting of ERCP.
详细描述
This study is a prospective, double-blind, randomized controlled trial. Patients who meet the criteria of our center and need to undergo ERCP lesion resection will be included and randomly divided into groups. After receiving Glycopyrrolate (experimental group) and Anisodamine (control group), duodenal peristalsis, biliary and pancreatic treatment time and postoperative nausea and vomiting will be observed during therapeutic ERCP. The inhibitory effect of Glycopyrrolate on postoperative nausea and vomiting of ERCP will be analyzed statistically.
Main outcome measure: incidence of nausea and vomiting after ERCP Secondary outcome measures: mean duodenal contractions per minute, duodenal spasm frequency and score, ERCP operation time, occurrence of other side effects of medication, remedial medication, and incidence of adverse events
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
- •1.Adults 18-80 years old 2.ASA :I-III 3.Patients who are able to give informed consent and are currently planning to have the lesion removed or examined at the descending ERCP
排除标准
- •1: Use of anticholinergic drugs
- •2: pregnancy
- •3: glaucoma
- •4: Myasthenia gravis
- •5: Obstructive gastrointestinal diseases
- •6: Obstructive urinary tract disease (prostatic hyperplasia)
- •7: Heart disease (coronary heart disease, congestive heart failure)
- •8: hyperthyroidism
- •9: Previous history of abdominal or intestinal surgery
- •10: Chronic renal failure
研究组 & 干预措施
Glycopyrrolate
During induction of anesthesia, 0.2mg Glycopyrrolate was given intravenously to participants.
干预措施: Glycopyrrolate (Drug)
Anisodamine Group
During induction of anesthesia,10mg of Anisodamine was given intramuscular injection
干预措施: Anisodamine (Drug)
结局指标
主要结局
Incidence of postoperative nausea and vomiting
时间窗: Timepoint：24 hours after the ERCP
次要结局
未报告次要终点
研究者
Jie Chen
Clinical Professor
The Second Affiliated Hospital of Chongqing Medical University