Haloperidol Compared to Dexamethasone in Lowering Postoperative Nausea and Vomiting and Pain in Adult After Laparoscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Nausea and Vomiting
研究概览
简要总结
This study aim to find out the effectiveness of 1 mg intravenous haloperidol compared to 5 mg intravenous dexamethasone to prevent the occurrence of nausea and vomiting also as pain control in adult patients after laparoscopic surgery.
详细描述
Eighty subjects (n=40 for each group) scheduled for laparoscopic-assisted surgery were enrolled in a randomized double-blind clinical trial. One milligram intravenous haloperidol was given one hour before the end of surgery, while 5 mg intravenous dexamethasone was given right after induction. The occurrence of Postoperative Nausea and Vomiting (PONV) and visual analog scale (VAS) pain score were recorded.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •underwent laparoscopic surgery (gynecology, digestive, or urology surgery)
- •American Society of Anesthesiologist (ASA) physical status 1-3
排除标准
- •psychological or neurological disorders (routine haloperidol consumption)
- •history of allergic reaction to dexamethasone or haloperidol
- •diabetes mellitus
- •did not give the consent
研究组 & 干预措施
Dexamethasone
5 mg intravenous dexamethasone
干预措施: Dexamethasone injection (Drug)
Haloperidol
1 mg intravenous haloperidol
干预措施: Haloperidol Injection (Drug)
结局指标
主要结局
Nausea and Vomiting
时间窗: Within 24 hours postoperative
Number of patients experiencing nausea and vomiting postoperative
次要结局
- Pain and VAS(0-2 hours, 2-6 hours, 6-12 hours, and 12-24 hours postoperative)
研究者
Aldy Heriwardito
Principal Investigator
Indonesia University