CTRI/2021/05/033600尚未招募不适用
A COMPARATIVE STUDY OF EFFICACY OF INTRATHECAL 0.5% BUPIVACAINE WITH DEXMEDETOMIDINE VS 0.5% BUPIVACAINE WITH FENTANYL IN PATIENTS UNDERGOING LOWER LIMB ORTHOPAEDIC SURGERIES : A RANDOMISED DOUBLE BLIND CONTROLLED TRIAL .
MGIMS Sevagram1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2021年1月7日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- The objectives of this study is to compare effects of intrathecal 0.5% Bupivacaine with Dexmeditomidine & 0.5% Bupivacaine with Fentanyl in terms of the duration of sensory and motor blockade.
研究概览
简要总结
A Randomised Double Blind Controlled Trail to study the efficacy of intrathecal 0.5% Bupivacaine with Dexmedetomidine vs 0.5% Bupivacaine with Fentanyl in 104 patients of lower limb orthopaedic surgeries. The primary objective is to study the duration of anaesthesia. The secondary objectives are to compare onset of block, level of bock , side effects and postoperative analgesia .
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anesthesiologists Grade I and II patients.
- •Age 20-60 years of either gender.
- •Patients undergoing lower limb Surgeries .
- •Patients free from cardiac and respiratory dysfunction.
- •Height is more than 4 feet.
排除标准
- •American Society of Anesthesiologists Grade III and IV patients.
- •Patients with known contraindications for spinal anaesthesia: bleeding disorders, local infection.
- •Patients with haemodynamic instability.
- •Patients with comorbidities like Hypertension, Diabetes Mellitus, cardiac diseases,etc.
- •Patient with allergy to or history of hypersensitivity to local anaesthetics.
- •Emergency surgeries.
- •Patient with known allergy to opioids.
- •Patients with a history of severe PDPH or PONV after spinal anaesthesia.
- •Patient’s refusal.
- •Orthopaedic Surgeries requiring level of block above T
- •Lower limb orthopaedic surgeries around Hip joint.
- •Joint replacement surgeries.
- •Orthopaedic surgeries requiring prolonged duration of action that will require supplementation with epidural catheterization or general anaesthesia.
结局指标
主要结局
The objectives of this study is to compare effects of intrathecal 0.5% Bupivacaine with Dexmeditomidine & 0.5% Bupivacaine with Fentanyl in terms of the duration of sensory and motor blockade.
时间窗: Till 120 minutes
次要结局
- The objectives of this study is to compare effects of intrathecal 0.5% Bupivacaine with Dexmedetomidine & 0.5% Bupivacaine with Fentanyl in terms of The onset of sensory and motor blocks achieved.(The level of blockade achieved .)
研究者
研究点 (1)
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