A Prospective,randomized,interventional study to compare the effect of duration of sitting posture in saddle block characteristics and haemodynamic changes with 0.5% bupivacaine(hyperbaric) in patients undergoing perineal surgeries
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 1)To assess and compare the haemodynamic changes from baseline Pulse rate(PR), Blood pressure(BP), Mean arterial pressure(MAP), sPO2.
研究概览
简要总结
The sitting position is used for patients undergoing spinal anesthesia especially when lower lumbar and sacral levels of sensory anesthesia are required. An advantage associated with this position is that the complications associated with it can be reduced. This study assess the relation between saddle block characteristics and haemodynamic changes and duration of sitting position.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant 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 elective perineal surgical procedures.
- •Patients willing to give written informed consent.
- •American Society of Anaesthesiologists (ASA)grade 1 and 2.
排除标准
- •Medically not fit for spinal anesthesia.
结局指标
主要结局
1)To assess and compare the haemodynamic changes from baseline Pulse rate(PR), Blood pressure(BP), Mean arterial pressure(MAP), sPO2.
时间窗: 1)Every 2 minutes for 10 minutes and every 5 minutes until 30 minutes. | 2)Every 5 minutes till 30 minutes. | 3)Every 5 minutes till 30 minutes.
2)To assess and compare the onset,duration and extent of motor blockade.
时间窗: 1)Every 2 minutes for 10 minutes and every 5 minutes until 30 minutes. | 2)Every 5 minutes till 30 minutes. | 3)Every 5 minutes till 30 minutes.
3)To assess and compare the onset ,duration and extent of sensory blockade.
时间窗: 1)Every 2 minutes for 10 minutes and every 5 minutes until 30 minutes. | 2)Every 5 minutes till 30 minutes. | 3)Every 5 minutes till 30 minutes.
次要结局
- To compare the proportion of cases with side effects.(Every 5 minutes)
研究者
Dr Manoj Soni
SMS Medical College and attached Hospitals, Jaipur