Intravenous Haloperidol Versus Ondansetron for Treatment of Established Nausea and Vomiting in Patients Undergoing Surgery With General Anesthesia: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The success of the anti-emetic administered in treating the postoperative nausea and vomiting (PONV)
研究概览
简要总结
This study aims to prove that at a dose of 1 mg Haloperidol possesses a high success rate in controlling established postoperative nausea and vomiting (PONV) in the first 24 hours following administration similar to the standard of care ondansetron 4 mg.
详细描述
Patients undergoing surgery under general anesthesia may experience several complications in their postoperative period. Nausea and vomiting are some of the more common of these complications. Several medications can be used for prevention of these specific complications, but treatment remains more cost-efficient.
Haloperidol is anti-psychotic which, at low doses, can prevent the occurrence of nausea and vomiting. Its usefulness for prophylaxis has been demonstrated in several studies. However, its use for treating established postoperative nausea and vomiting (PONV) has not been properly studied.
In a prospective randomized clinical trial involving adult patients undergoing elective surgery under general anesthesia, investigators will enroll 120 patients, and compare the effect of a dose of 1 mg Haloperidol versus Ondansetron 4 mg and document the varying degrees of success in treating nausea and vomiting as well as possible side effects.
Investigators expect to observe that Haloperidol is as effective as treatment with Ondansetron.
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
- Double (Participant, 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
- 否
入选标准
- •Patients aged 18-80
- •ASA class I, II, and III
- •undergoing elective surgery under general anesthesia
排除标准
- •Patients with history of arrhythmias, QTc prolongation or allergies to the study drugs will be excluded from the study.
研究组 & 干预措施
Group I
Patients will receive 4 mg of Ondansetron IV upon occurrence of nausea or vomiting
干预措施: 4 mg of Ondansetron IV (Drug)
Group II
Patients will receive 1mg of Haloperidol IV upon occurrence of nausea or vomiting
干预措施: 1mg of Haloperidol IV (Drug)
结局指标
主要结局
The success of the anti-emetic administered in treating the postoperative nausea and vomiting (PONV)
时间窗: during the first hour postoperatively
Investigators will assess the success rate of the anti-emetic used: resolution of post-operative nausea and vomiting within 30 minutes from the adminstration of the anti-emetic will be considered "success".
次要结局
- Severity of postoperative nausea and vomiting (PONV)(during the first 24 hours postoperatively)
- Recurrence of postoperative nausea and vomiting (PONV)(during first 24 hours postoperatively)
- Side effects in PACU(1 hour postoperatively)
- Patient satisfaction(24 hours after surgery)
- Rescue anti-emetic(during the first 24 hours postoperatively)
研究者
Dr. Marie Awad
Professor of Clinical Specialty
American University of Beirut Medical Center