Comparison of intrathecal Dexmedetomidine and Fentanyl as adjuvant to Hyperbaric Bupivacaine in orthopedic lower limb surgeries- A double blind randomized control study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To compare time of two segment regression from highest sensory level(min) with Dexmedetomidine and Fentanyl as adjuvant to Hyperbaric Bupivacaine intrathecally in orthopedic lower limb surgeries
研究概览
简要总结
A double blind randomized control study conducted to compare intrathecal dexmedetomidine and fentanyl as adjuvant to hyperbaric bupivacaine in orthopedic lower limb surgeries done under spinal anesthesia.
64 patients divided into 2 groups with 32 each, first group( group D) will receive 5mcg dexmedetomidine added to 2.5ml of 0.5% hyperbaric bupivacaine and next group( group F) will receive 25mcg fentanyl added to 2.5 ml of 0.5% hyperbaric bupivacaine intrathecally.
Both sensory and motor status of patient will be assessed immediately after spinal injection, then every 2 minutes until reaching highest sensory level and Bromage scale 3. Then assessed every 10 minute till 2 segment sensory regression is seen. Then assessed every 20 minutes till sensory regression to S1 and Bromage 0.
Severity of pain 2 and 4 hours after surgery will be measured by numeric rating scale(NRS).
Time for 2 segment regression is more in group D than in group F patients
We are also expecting longer duration sensory and motor blockade and longer post operative analgesia in group D patients
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
- 20.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients belonging to ASA physical status 1 and 2 Patients giving informed valid written consent Patients undergoing elective orthopedic lower limb surgeries under spinal anaesthesia.
排除标准
- •Patients posted for emergency surgeries Patients having uncontrolled hypertension or diabetes mellitus Patients with renal or hepatic failure, cardiac block or dysrhythmia, coagulopathies, neurologic disorders Patients having hypersensitivity to any of the study groups Patients with known contraindications to spinal anaesthesia.
结局指标
主要结局
To compare time of two segment regression from highest sensory level(min) with Dexmedetomidine and Fentanyl as adjuvant to Hyperbaric Bupivacaine intrathecally in orthopedic lower limb surgeries
时间窗: after injecting drug sensory and motor status assessed every 2min till it reaches highest sensory level and bromage 3, then every 10min till 2segment regression, then every 20min till it regresses to S1 sensory level and bromage 0
次要结局
- to compare characteristics of block between 2 groups in view of(1.time from injection to highest sensory level)