NCT05265507Unknown4 期
Comparison of Anti-nausea and Vomiting Effect After Elective Surgery Undergoing General Anesthesia Between Glycopyrronium and Ondansetron: a Multi-center Study
The Second Affiliated Hospital of Chongqing Medical University1 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2022年3月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- incidence of postoperative nausea and vomiting
研究概览
简要总结
To compare the anti-nausea and vomiting effect between glycopyrronium and ondansetron for patients receiving elective surgery under general anesthesia. Based on this study the investigators intend to explore the feasibility of using glycopyrronium to prevent postoperative nausea and vomiting.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists classification I-III
- •Receive general anesthesia
- •Voluntarily receive postoperative intravenous controlled analgesia
排除标准
- •Puerpera or lactation women
- •Allergy or existing contraindication to glycopyrronium and ondansetron
- •Participate in other clinical drug trials within three months
- •Can not follow with the study procedure
研究组 & 干预措施
Glycopyrronium
Experimental
Glycopyrronium (0.2mg) was intravenously given at the ending of the surgery.
干预措施: Glycopyrronium (Drug)
Ondansetron
Active Comparator
Ondansetron (4mg) was intravenously given at the ending of the surgery.
干预措施: Ondansetron (Drug)
结局指标
主要结局
incidence of postoperative nausea and vomiting
时间窗: from the ending of surgery to 24 hours after surgery
postoperative nausea and vomiting is recorded according to follow-up visits after surgery
次要结局
- incidence of intervention requirement for nausea and vomiting(from the ending of surgery to 24 hours after surgery)
- incidence of postoperative vomiting(from the ending of surgery to 24 hours after surgery)
- intensity of postoperative nausea(from the ending of surgery to 24 hours after surgery)
研究者
研究点 (1)
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