Phase 4 Study of Optimal Dose of Haloperidol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Incidence of Postoperative Nausea and Vomiting
研究概览
简要总结
Low-dose haloperidol is known to be effective for the treatment of postoperative nausea and vomiting (PONV). However, precise dose-response studies have not been completed, especially in patients at high risk for PONV who require combination therapy. This study sought to identify the optimal dose of haloperidol that could be combined with dexamethasone without adverse effects in high-risk PONV patients receiving intravenous patient-controlled anesthesia (IV PCA) after gynecological laparoscopic surgery.
详细描述
Female adults with three established PONV risk factors based on Apfel's score were randomised into one of three study groups. At the end of anaesthesia, groups H0, H1, and H2 were given intravenous (IV) saline, haloperidol 1 mg, and haloperidol 2 mg, respectively. All patients were given dexamethasone during the induction of anaesthesia. The overall early (0-2 h) and late (2-24 h) incidences of nausea, vomiting, rescue anti-emetic administration, pain, and adverse effects (cardiac arrhythmias and extrapyramidal effects) were assessed postoperatively. The sedation score was recorded in the postanaesthesia care unit (PACU).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •ASA physical status I or II women
- •Aged 20 65 years, and scheduled for gynecologic laparoscopic surgery and IV patient-controlled analgesia (PCA) for postoperative pain control.
排除标准
- •Known allergy or intolerance to the study drug
- •History of cardiac arrhythmia
- •Psychiatric illness
- •Chronic treatment with a dopamine antagonist
- •Use of opioids or steroids within one week of surgery
- •Use of antiemetic within 24 hours before the study
- •No ability to use the PCA device
- •Gastrointestinal, renal, or hepatic disease
- •Insulin-dependent diabetes or obesity with a body mass index > 35 kg/m2.
研究组 & 干预措施
dexamethasone
dexamethasone 5mg iv during anesthesia induction
干预措施: Dexamethasone iv injection (Drug)
dexamethasone, haloperiol 1mg
dexamethasone 5mg iv during anesthesia induction & haloperidol 1mg iv 30 min before end of anesthesia
干预措施: Dexamethasone, haloperidol (Drug)
dexamethasone + haloperidol 2mg
dexamethasone 5mg iv during anesthesia induction & haloperidol 2mg iv 30 min before end of anesthesia
干预措施: Dexamethasone, haloperidol (Drug)
结局指标
主要结局
Incidence of Postoperative Nausea and Vomiting
时间窗: postoperative 24 hours
incidence of nausea, vomiting and requirement for rescue antiemetics
次要结局
- Incidence of Extrapyramidal Symptoms(postoperative 24 hours)
- Incidence of Cardiac Arrhythmia(postoperative 2 hours)
- Sedation Change in Recovery Room(postoperative 30, 60, 90, and 120 min)
研究者
Young Eun Moon
clinical associate professor
The Catholic University of Korea