Ketamine for Analgesia After Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Dynamic Visual Analog Scale
研究概览
简要总结
In this prospective randomized trial, investigators compared the analgesic effect of subanesthetic dose of ketamine versus placebo in parturients undergoing cesarean section under spinal anesthesia.
详细描述
In this prospective randomized trial, investigators compared the analgesic effect of subanesthetic dose of ketamine versus placebo in parturients undergoing cesarean section under spinal anesthesia.
The patients were randomized in two groups:
- Group Ketamine: these patients recieved 0.25 mg/kg of Ketamin intravenously 5 minutes after the spinal anesthesia.
- Group Placebo: recieved 20 ml of normal saline solution intravenously 5 minutes after the spinal puncture.
The investigators recorded intra demographic, intraoperative and post operative data.
The main outcome was the analgesic score: the visual analog scale (VAS). dynamic VAS was also monitored at 24 hours post operatively.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •full term pregnant adult patients
- •Monofetal pregnancy
- •scheduled for urgent or elective cesarean section under spinal anesthesia
排除标准
- •necessity of general anesthesia during the procedure
- •Post partum hemorrage
研究组 & 干预措施
Ketamine Group
Patients recieving 0.25 mg/kg of ketamine 5 minutes after spinal anesthesia
干预措施: 0.25 mg/kg of Ketamine (Drug)
Placebo Group
干预措施: 20ml of normal saline solution (Drug)
结局指标
主要结局
Dynamic Visual Analog Scale
时间窗: 24 hours after cesarean section
Pain score VAS range from 0 to 10, high scores mean worse outcome
次要结局
未报告次要终点
研究者
Mhamed Sami Mebazaa
Professor, head of department of anesthesia and critical care
Mongi Slim Hospital