Comparison of efficacy of hyperbaric bupivacaine pre-mixed with fentanyl versus sequential administration of fentanyl followed by hyperbaric bupivacaine in lower abdominal surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Compare the onset and completion of sensory and motor blockade in both groups
研究概览
简要总结
Due to the limited duration of spinal anaesthesia, opioids have been added to local anaesthetics to increase the duration and improve the quality of spinal block. Fentanyl has been considered as the adjuvant of choice owing to its potency, fast onset, short duration of action and lower incidence of respiratory depression.This study is being done to compare the onset and completion of the block, hemodynamic profile, duration of block, rescue analgesia requirement and adverse events of sequential administration of intrathecal fentanyl and bupivacaine to the routine mixing of the two drugs in patients posted for lower abdominal surgeries under spinal anaesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing lower abdominal surgery American Society of Anaesthesiologits Grade 1 and 2.
排除标准
- •Patients with history of opioid intake Patients who refuse to participate in the study Patients with known allergy to drugs used in the study.
结局指标
主要结局
Compare the onset and completion of sensory and motor blockade in both groups
时间窗: The sensory and motor blockade will be assessed continuously till the achievment of onset and completion of blockade (5-20 mins).
次要结局
- Compare the hemodynamic effect, duration of block, requirement of rescue analgesia and adverse events in both groups(Immedicately after the block and at every 1 minute interval for the first 5 minutes and then till 10 minutes)
研究者
Dr Sagnik Datta Majumdar
Chirayu Medical College and Hospital