Efficacy of Different Doses of Fentanyl With Intrathecal Low Dose Levobupivacaine on Recovery profile in cesarean section A Prospective Randomized Double Blind Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 285
- 试验地点
- 1
- 主要终点
- Time for complete recovery from Motor block After giving spinal anaesthesia
研究概览
简要总结
The aim of study is to evaluate the effect of different doses of fentanyl with low dose levobupivacaine on recovery profile in cesarean section.
284 Pregnant women will be divided into three groups, In each group there will be 95 patient come who are posted for elective cesarean section.
In group LF 10 , 0.5% Levobupivacaine heavy 7.5 mg+ fentanyl 10 microgram(0.2 ml) + 0.3 ml Normal saline, Total 2.0 ml drug given.
In group LF 15, 0.5% Levobupivacaine heavy 7.5 mg+ fentanyl 15 microgram(0.3 ml)+ 0.2 ml Normal saline, Total 2.0 ml drug given.
In group LF 20, 0.5% Levobupivacaine heavy 7.5 mg+ fentanyl 20 microgram(0.4 ml)+ 0.2 ml Normal saline, Total 2.0 ml drug given.
Time for complete recovery from Motor block as primary outcome.
As secondary outcome two segment regression time, time for complete recovery from sensory block( Duration of sensory block), Time to achieve T4-T6, Duration of Analgesia, patient satisfaction score, hemodynamic parameters, apgar score in newborn, any side effects like nausea, vomiting, hypotension, tachycardia/ bradycardia, respiratory depression, pruritus, high spinal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •ASA Grade II patients planned for cesarean section under spinal anaesthesia.
- •Able to understand study procedure and given consent.
排除标准
- •Refusal to take part in study
- •Coagulopathy/ Sickle cell disease/ Diabetes Mellitus/ Hypertensive Disorder/ Eclampsia/ Anaemia
- •Allergy or Contraindication to study drugs
- •Pre-mature rupture of membrane, bleeding P/V, uterine abnormality.
结局指标
主要结局
Time for complete recovery from Motor block After giving spinal anaesthesia
时间窗: from zero minute after giving spinal anaesthesia
次要结局
- 1. Two segment regression time(2. Time for Complete recovery from sensory block (Duration of sensory block))
研究者
Dr Hemangini Patel
Government medical college, Baroda