Effects of IV Dexmedetomidine on Spinal Anaesthesia in Lower Limb Orthopedic Surgeries.Randomized double blinded placebo controlled study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Duration for conducting the spinal block
研究概览
简要总结
—Orthopaedic procedures of lower limbs are best doneunder spinal anaesthesia but the major problem is positioning the patient forspinal block
—Due to the injury and pain, longer time is taken forpositioning and to achieve a successful Dural tap.
—The discomfort and distress of positioning requiresprior administration of strong IV narcotics, which have the disadvantage ofover sedation, respiratory depression & poor co-operation
—Dexmedetomidine is a very potent a2 agonist which causesdose dependent sedation, anxiolysis ,some analgesia, blunting stress responseand also with opioid sparing effect
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and 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
- •Asa status 1&2 Patients undergoing lower limb orthopedic surgery.
排除标准
- •PATIENTS WITH SINUS BRADYCARDIA PATIENTS WITH ARRYTHMIA ANY CONTRAINDICATIONS FOR SPINAL ANAESTHESIA HISTORY OF DRUG HYPERSENSITIVITY PATIENTS REFUSAL.
结局指标
主要结局
Duration for conducting the spinal block
时间窗: Level of sensory block and quality of motor block at 5 min of spinal anaesthesia till 15 minutes. |  Time for two segment regression after completion of surgical procedure. |  Level of sedation (Ramsay sedation score) at 15minutes interval till the patient discharge from post anaesthesia care unit or fully alert. | Post operative pain ( VAS score), time to requirement of 1st rescue analgesia, and total rescue doses in first 24 hours
Quality and duration of spinal block
时间窗: Level of sensory block and quality of motor block at 5 min of spinal anaesthesia till 15 minutes. |  Time for two segment regression after completion of surgical procedure. |  Level of sedation (Ramsay sedation score) at 15minutes interval till the patient discharge from post anaesthesia care unit or fully alert. | Post operative pain ( VAS score), time to requirement of 1st rescue analgesia, and total rescue doses in first 24 hours
Post operative pain & analgesia requirement
时间窗: Level of sensory block and quality of motor block at 5 min of spinal anaesthesia till 15 minutes. |  Time for two segment regression after completion of surgical procedure. |  Level of sedation (Ramsay sedation score) at 15minutes interval till the patient discharge from post anaesthesia care unit or fully alert. | Post operative pain ( VAS score), time to requirement of 1st rescue analgesia, and total rescue doses in first 24 hours
SPINAL BLOCK.
时间窗: Level of sensory block and quality of motor block at 5 min of spinal anaesthesia till 15 minutes. |  Time for two segment regression after completion of surgical procedure. |  Level of sedation (Ramsay sedation score) at 15minutes interval till the patient discharge from post anaesthesia care unit or fully alert. | Post operative pain ( VAS score), time to requirement of 1st rescue analgesia, and total rescue doses in first 24 hours
POST OPERATIVE PAIN AND ANALGESIA REQUIREMENT.
时间窗: Level of sensory block and quality of motor block at 5 min of spinal anaesthesia till 15 minutes. |  Time for two segment regression after completion of surgical procedure. |  Level of sedation (Ramsay sedation score) at 15minutes interval till the patient discharge from post anaesthesia care unit or fully alert. | Post operative pain ( VAS score), time to requirement of 1st rescue analgesia, and total rescue doses in first 24 hours
次要结局
- Level of sedation(Hemodynamic changes)