Etude de l'Effet du dropéridol et de l'Ondansetron Sur l'Incidence de l'Akathisie Post opératoire en Chirurgie Ambulatoire
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of akathisia
研究概览
简要总结
The main objective of this study is to evaluate the incidence of akathisia with Droperidol, the prophylactic treatment of post operative nausea and vomiting, used at two different doses, versus control group (Ondansetron), in outpatient surgery.The primary endpoint is to compare the number of observed akathisia (Barnes score > 1) in the Droperidol arms (0,625 mg and 1,25 mg) versus Ondansetron 4 hours after recovery from anesthesia.The assumption is that there is a greater risk of akathisia among patients taking Droperidol in prevention of NPVO, that among patients taking Ondansetron.
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, 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
- •Patient over 18 and under 65 year-old
- •Having a moderate to severe POVN (post operative vomiting and nausea) risk, meaning with at least two risk factors in the simplified Apfel score
- •Outpatient surgery associated to a general anesthesia
- •Patient having signed an informed consent- Patient having a social protection
排除标准
- •Contraindication to Droperidol
- •Contraindication to Ondansetron
- •Patients usually treated with benzodiazepine or having been treated with benzodiazepine within 2 days prior to anesthesia
- •Psychiatric and Neurodegenerative diseases
- •Severe Anxiety
- •Contraindication to general anesthesia or one of its components
- •Allergy to propofol
- •Inability to get informed (patient in an emergency situation, difficulties to understand)
- •Patient under judicial protection
- •Patient under tutorship or curatorship
- •Pregnancy reported by the patient- Breastfeeding
- •Patient in an exclusion period
研究组 & 干预措施
Arm 3 : Odansetron 4 mg
干预措施: Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration (Drug)
Arm 1 : Droperidol 1,25 mg
干预措施: Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration (Drug)
Arm 2 : Droperidol 0,625 mg
干预措施: Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration (Drug)
结局指标
主要结局
Incidence of akathisia
时间窗: 1 day
The main objective of this study was to evaluate the incidence of akathisia with the waning of prophylactic treatment of PONV with droperidol used two different doses versus control group (ondansetron), ambulatory surgery
次要结局
未报告次要终点