Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section
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
- Total opioid requirement postoperatively
研究概览
简要总结
This randomized double blind study will be conducted in pregnant woman planned for non elective cesarean section under spinal anesthesia. Ketamine group will receive intravenous 0.25 mg/kg and placebo group will receive same amount of normal saline after spinal anesthesia prior to skin incision. Postoperative outcomes measures are total opioid consumption and pain scores for 24 hrs.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• All women at term(>or =37 weeks of gestation)
- •American Society of Anesthesiologists(ASA) class1 and 2
- •Women undergoing non-elective caesarean section whose anesthetic plan is for spinal anesthesia with bupivacaine and fentanyl
排除标准
- •• Women with American society of anesthesiologist physical status>2
- •Body mass index >or =40 kg per square meter
- •Height <150 cm
- •Any contraindication to the spinal anesthesia
- •History of substance abuse
- •History of hallucinations
- •Chronic opioid therapy
- •Chronic pain or on any pain medication currently
- •Patient with maternal complications,like cardiovascular disease pre-eclampsia,diabetes,multiple gestation,known fetal abnormality
- •Cases with severely compromised fetus where immediate administration of general anesthesia is required.
研究组 & 干预措施
analgesic effects of ketamine
the experimental group will receive ketamine intravenously at 0.25 mg per kg before skin incision.
干预措施: Ketamine (Drug)
placebo
they will receive same volume of 0.9% normal saline as calculated for experimental group before skin incision.
干预措施: Placebo (Drug)
结局指标
主要结局
Total opioid requirement postoperatively
时间窗: 24 hrs
Total opioid required up to 24 postoperatively in ketamine and placebo group.
次要结局
- Time to first perception of pain(24 hrs)
- Incidence of side effects(24 hrs)
- Postoperative numerator rating scores(NRS)up to 24 hrs . postoperative )(24 hrs)
研究者
prahlad adhikari
doctor
B.P. Koirala Institute of Health Sciences