AN OBSERVATIONAL STUDY OF COMPARISION BETWEEN INTRA-THECAL HYPERBARIC BUPIVACAINE 0.5% 3.3cc WITH DEXMEDATOMEDINE 10Mcg VERSUS HYPERBARIC BUPIVACAINE 0.5% 3.3cc WITH NALBUPHINE 1 mg IN LOWER LIMB ORTHOPAEDIC SURGERIES
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
- to Compare efficacy of dexmedatomedine and
研究概览
简要总结
The purpose of this study is to compare the efficiacy of 2 days (inj. dexmedatomedine 10 mcg and inj. Nalbuphine 1mg) in spinal anesthesia in blunting the hemodynamic response and post operative analegsia in spinal anaesthesia in lower limb orthopeadic surgeries.
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 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 willing to sign the informed written consent. Patients of ASA Grade I and II of either gender. Under Spinal anaesthesia for elective pelvic and lower limb surgeries Aged
- •60 years. No known history of allergy, sensitivity to local anaesthetics of the amide group and other drugs used for this study.
排除标准
- •Patient refusal.
- •â— Patient not NIL by mouth.
- •â— History of seizure disorder.
- •â— Known allergy to trial drugs.
- •â— Patients with neurological disorders and neuropathies or receiving medications known to influence neuromuscular junction.
- •â— ASA III, IV, V Patients.
- •â— Patient with prior pre-existing Comorbidities (Heart diseases, Respiratory disease, Kidney diseases, known fetal abnormalities) â— Pregnant females â— Failed spinal anesthesia converted to general anesthesia â— Any contraindication to Spinal Anaesthesia (local site infection, spine deformity, clotting abnormalities.
- •Patients fulfilling above inclusion criteria are taken for study.
结局指标
主要结局
to Compare efficacy of dexmedatomedine and
时间窗: Baseline | 0 min | 2 mins | 5 mins | 10 mins | 15 mins | 20 mins | 30 mins | 45 mins | 60 mins | 75 mins | 90 mins | 120 mins | 150 mins | 180 mins
nalbuphine in blunting hemodynamic response
时间窗: Baseline | 0 min | 2 mins | 5 mins | 10 mins | 15 mins | 20 mins | 30 mins | 45 mins | 60 mins | 75 mins | 90 mins | 120 mins | 150 mins | 180 mins
and post operative analesgia in patient recieving
时间窗: Baseline | 0 min | 2 mins | 5 mins | 10 mins | 15 mins | 20 mins | 30 mins | 45 mins | 60 mins | 75 mins | 90 mins | 120 mins | 150 mins | 180 mins
Spinal anaesthesia in lower limb orthopedic
时间窗: Baseline | 0 min | 2 mins | 5 mins | 10 mins | 15 mins | 20 mins | 30 mins | 45 mins | 60 mins | 75 mins | 90 mins | 120 mins | 150 mins | 180 mins
surgeries
时间窗: Baseline | 0 min | 2 mins | 5 mins | 10 mins | 15 mins | 20 mins | 30 mins | 45 mins | 60 mins | 75 mins | 90 mins | 120 mins | 150 mins | 180 mins
次要结局
- to compare duration of post operative analgesia in group dexmedatomedine and group nalbuphine(time at which rescue analgesia was given.)
研究者
Kartik H Sangam
Smt. Bhikiben Kanjibhai Shah Medical Institute and research Centre