RANDOMIZED DOUBLE-BLIND STUDY TO COMPARE INTRATHECAL 1% 2-CHLOROPROCAINE WITH FENTANYL AND 0.5% ROPIVACAINE WITH FENTANYL FOR SHORT SURGERIES UNDER SPINAL ANAESTHESIA.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- . Post operative early regain of sensory block and motor block.
研究概览
简要总结
The study is randomized ,double blind, trial comparing the efficacy between the two drugs intrathecal 1% 2- chloroprocaine and 0.5% ropivacaine with adjuvant fentany (12.5 mcg)l in spinal anaesthesia for short surgeries . primary outcome will be duration of anaesthesia and haemodynamic stability, secondary outcome will be early ambulation and early discharge.
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 Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA I/II for selection of patient.
- •duration of surgery less than 2 hrs.
排除标准
- •Patients Refusal 2)infection on spinal region.
- •Patients with a history of severe cardiovascular disease, steroid use, renal or hepatic dysfunction and mental retardation 4)Known sensitivity to the drug to be used 5)Patients on anticoagulant therapy, coagulation disorder 6)Intolerance to Atypical plasma cholinesterase.
结局指标
主要结局
. Post operative early regain of sensory block and motor block.
时间窗: observation of motor and sensory block after spinal anaesthesia in short surgeries every 5 mins for 20 mins then every 10 mins upto end of surgery | 2.Heart rate ,systolic blood pressure, diastolic blood pressure ,respiratory rate , oxygen saturation for every 5 mins for 10 minutes then every 10 minutes upto end of surgery
Haemodynamic stability after giving spinal anaesthesia in short surgeries.
时间窗: observation of motor and sensory block after spinal anaesthesia in short surgeries every 5 mins for 20 mins then every 10 mins upto end of surgery | 2.Heart rate ,systolic blood pressure, diastolic blood pressure ,respiratory rate , oxygen saturation for every 5 mins for 10 minutes then every 10 minutes upto end of surgery
. Duration of surgery
时间窗: observation of motor and sensory block after spinal anaesthesia in short surgeries every 5 mins for 20 mins then every 10 mins upto end of surgery | 2.Heart rate ,systolic blood pressure, diastolic blood pressure ,respiratory rate , oxygen saturation for every 5 mins for 10 minutes then every 10 minutes upto end of surgery
次要结局
- Early ambulation after surgery(.Early discharge of patient.)