A Randomized Double-Blind Study to Compare the Effect of Speed of Injection (15 sec versus 60 sec) of 0.5% Heavy Bupivacaine on Quality of Block And Hemodynamic Parameters in Patients Scheduled for Infra Umbilical Surgery Under Spinal Anesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean time of onset of sensory block.
研究概览
简要总结
In anesthetic practice, spinal anesthesia is the most often used technique for gynaecological ,lower abdominal, pelvic and lower limb procedures. The advantage of spinal anesthesia is that it can cause a profound nerve block with only a modest dose of local anesthetic injection. There is a scarcity of data on the effect of speed of injection while administering hyperbaric solutions for spinal block. Although higher distribution of sensory blockade has been observed with a slower speed of injection, most researches using a hyperbaric local anesthetics have not reported difference in anesthetic characteristics. With this background we plan to conduct this study to compare the effect of speed of injection(15 sec versus 60 sec) of 0.5%heavy bupivacaine on quality of block and haemodynamic parameters in patients scheduled for infra umbilical surgery under spinal anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex scheduled to undergo elective infra umbilical surgical procedure under spinal anaesthesia.
- •Patient giving written informed consent.
- •ASA Grade I and II.
排除标准
- •Patient who is part of any other study.
- •Non co-operative patient.
- •Patients with infection at the injection site.
- •Patients with thrombocytopenia or coagulopathy.
- •Patients with allergy to study drug.
结局指标
主要结局
Mean time of onset of sensory block.
时间窗: Baseline, Just after SAB,2 min,4 min,6 min,8 min,10 min,15 min,20 min,25 min,30 min,35 min,40 min,45 min,50 min,55 min,60 min,65 min,70 min.
Mean time of onset of motor block.
时间窗: Baseline, Just after SAB,2 min,4 min,6 min,8 min,10 min,15 min,20 min,25 min,30 min,35 min,40 min,45 min,50 min,55 min,60 min,65 min,70 min.
Mean time to achieve T 10 dermatome block.
时间窗: Baseline, Just after SAB,2 min,4 min,6 min,8 min,10 min,15 min,20 min,25 min,30 min,35 min,40 min,45 min,50 min,55 min,60 min,65 min,70 min.
Mean block height at 5 minutes.
时间窗: Baseline, Just after SAB,2 min,4 min,6 min,8 min,10 min,15 min,20 min,25 min,30 min,35 min,40 min,45 min,50 min,55 min,60 min,65 min,70 min.
Mean of maximum sensory level achieved.
时间窗: Baseline, Just after SAB,2 min,4 min,6 min,8 min,10 min,15 min,20 min,25 min,30 min,35 min,40 min,45 min,50 min,55 min,60 min,65 min,70 min.
Mean of haemodynamic parameters (HR,SBP,DBP,MAP).
时间窗: Baseline, Just after SAB,2 min,4 min,6 min,8 min,10 min,15 min,20 min,25 min,30 min,35 min,40 min,45 min,50 min,55 min,60 min,65 min,70 min.
Mean time taken for onset of hypotension.
时间窗: Baseline, Just after SAB,2 min,4 min,6 min,8 min,10 min,15 min,20 min,25 min,30 min,35 min,40 min,45 min,50 min,55 min,60 min,65 min,70 min.
Mean dose of Mephentermine required to correct hypotension.
时间窗: Baseline, Just after SAB,2 min,4 min,6 min,8 min,10 min,15 min,20 min,25 min,30 min,35 min,40 min,45 min,50 min,55 min,60 min,65 min,70 min.
次要结局
- Proportion of cases with side effects (if any).(Up to 12 hours of surgery.)
研究者
Dr Kanchan Chauhan
SMS medical college and hospital