Role of Droperidol in Postoperative Vomiting: Phase IV Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Vomiting episodes
研究概览
简要总结
Protocol title: Role of low dose droperidol in postoperative vomiting
Purpose: Evaluate the efficacy of droperidol to postoperative nausea and vomiting when administrated at the introduction to anesthesia, prior to surgery
Design: Prospective, randomized, placebo-controlled study
Patient Population: Male or female subjects 18 years of age or older who are scheduled for laparoscopic cholecystectomy
No. of Subjects: 100 patients divided into two groups, estimated up to 6 months to enroll
Duration of Treatment: Prior operation
Duration of Follow-up: Follow-up will be performed for 24 hours postoperatively
Endpoints: To evaluate the effectiveness of low dose droperidol when administered Prior surgery
详细描述
In this prospective, randomized, placebo-controlled study, the researchers determined whether 0.625 mg (1/2 amp) IV droperidol given at the initiation of general anesthesia reduces the incidence of immediate and delayed post operative nausea and vomiting (PONV) in laparoscopic cholecystectomy population. One hundred patients receiving general anesthesia for laparoscopic cholecystectomy received droperidol 0.625 mg (1/2 amp) mg or placebo prior operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient more than 18 years old
- •Patients scheduled for laparoscopic cholecystectomy
- •Informed consent obtained from the patient
排除标准
- •Age < 18 years old
- •Contraindication to laparoscopic surgery
- •Present a severe depressive syndrome
- •Pregnancy women
- •Trouble of cardiac rate
- •Alcoholism
- •Contra-indication for Droperidol prescription
研究组 & 干预措施
A
Placebo Administrated 30min prior to operation
干预措施: Saline solution (Drug)
B
0.625 mg Droperidol administrated i.v 30 min prior surgery
干预措施: Droperidol (Drug)
结局指标
主要结局
Vomiting episodes
时间窗: 24 hours
次要结局
- Light nausea(24 hours)
- Control of nausea(24 hours)
- Anti-vomiting treatment(24 hours)
- Adverse events(24 hours)
- Modification of electrocardiograph(24 hours)