COMPARISON OF INTRATHECAL VERSUS INTRAVENOUS DEXMEDETOMIDINE AS AN ADJUVANT TO HYPERBARIC BUPIVACAINE FOR SUBARACHNOID BLOCK IN PATIENTS UNDERGOING LOWER LIMB ORTHOPEDIC SURGERIES
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To assess and compare in both groups onset and duration of motor and sensory blockade
研究概览
简要总结
This study will be conducted in Vydehi Indtuitute of medical sciences and Research Center recruiting patients posted for lower limb orthopedic surgeries. All patients will be receiving spinal anesthesia with Dexmedetomidine either as an adjuvant to spinal as 5 mcg intrathecally Or as an IV supplement at 0.5microgram per kg in 100 ml normal saline 15 minutes before spinal anesthesia.
The effect of this drug on the intervention will be measured in terms of onset and duration of motor and sensory blockade that the spinal anesthesia provides for these surgeries
The study will be conducted on 90 patients over a period of a year.
The results will he directed in the comparison of the two routes of administration of Dexmedetomidine as an adjuvant to spinal anesthesia in lower limb orthopedic surgeries.
The study shall also have secondary objectives of noting shivering sedation and any adverse effects due to the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Outcome Assessor 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 Limb orthopaedic surgeries under Neuraxial blockade.
- •Patients belonging to Americans Society of Anaesthesiologists physical status 1 and 2.
排除标准
- •Patients who did not consent 2) Allergies to Dexmedetomidine and Bupivacaine 3) Patients who underwent prolonged surgery requiring epidural activation 4) Emergency surgeries 5) Conversion to general Anesthesia 6) Localised infection at needle site 7) BMI> 35 kg/m2.
结局指标
主要结局
To assess and compare in both groups onset and duration of motor and sensory blockade
时间窗: at 0th minute , 3rd, 6th, 9th, 12th, 15th, 30th, 60th minute then at 2nd ,4th, 6th ,10th , 12th and 24th hour
次要结局
- Time to first rescue analgesia((Tramadol 50mg in 100ml normal saline))
- Total rescue analgesic doses given in 24 hours(Time at which rescue Analgesia given is noted.)
- Sedation scores(Intra operative sedation scores until the surgery is complete is noted.)
- Incidence of shivering(Intra operative from the time of intervention to completion of surgery.)
- Adverse effects (if any)(From the time of intervention up to 24 hours post procedure.)