Comparative study on analgesic efficacy of Midazolam versus Fentanyl as an adjuvant to 0.5% hyperbaric levobupivacaine in spinal anesthesia for patients undergoing elective lower limb surgeries a randomized interventional study at SMS medical college Jaipur

Department of Anesthesiology, S.M.S Medical College and Attached Hospitals1 个研究点分布在 1 个国家目标入组 70 人开始时间: 2023年12月9日最近更新: 2023年1月9日

试验速览

阶段: Phase 3 4
状态: 尚未招募
发起方
入组人数: 70
试验地点: 1
主要终点: To determine the average time for the need of first dose of rescue analgesia

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

In this study our aim is to find out which drug is better between Midazolam versus Fentanyl used as adjuvant with 0.5% Hyperbaric Levobupivacaine in achieving prolonged postoperative analgesia in patients undergoing elective lower limb surgeries under spinal anesthesia.

研究设计

研究类型: Interventional
分配方式: Other
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 20.00 Year(s) 至 60.00 Year(s)（—）
性别: All

入选标准

•Patient willing to participate in the study with written informed consent
•Patients age between 20 to 60 years
•Height of the patient is more than 145 cms
•Patients undergoing elective lower limb surgeries
•Patients belonging to ASA physical status I or II.

排除标准

•Patients with bacteremia sepsis or skin infection of local site
•Patient with severe hypovolemia or anemia or compromised renal cardiac or respiratory status
•Patients with raised intracranial tension
•Patients with abnormal coagulation profile
•Uncooperative patients
•Patients in whom spinal anesthesia failed and general anesthesia was required.

结局指标

主要结局

To determine the average time for the need of first dose of rescue analgesia

时间窗: Every 30 minutes for 6 hours postoperatively

次要结局

To determine the average time for the onset of sensory block(Every 2 minutes till highest level attained)
To determine the average time for the onset of motor block(Every 2 minutes till maximum motor block)
To determine the average duration of motor block(Every 30 minutes till 6 hours postoperatively)
To determine the average duration of sensory block(Every 30 minutes till 6 hours postoperatively)
To compare the changes in cardiocirculatory parameters ( HR, SBP, DBP, MBP)(Every 5 minutes for first 30 minutes followed by every 10 minutes till completion of surgery then every 30 minutes for 6 hours postoperatively)
To determine the VAS score(Every 30 minutes for 6 hours postoperatively)
Adverse events if any to be noted(24 hours)

研究者

发起方

Department of Anesthesiology, S.M.S Medical College and Attached Hospitals

申办方类型

Government medical college

研究点 (1)

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