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临床试验/CTRI/2025/11/097003
CTRI/2025/11/097003尚未招募2/3 期

Comparison of intrathecal bupivacaine versus intrathecal levobupivacaine with dexmedetomidine as an adjuvant for lower limb and lower abdominal surgeries

sapthagiri institute of medical science and research center1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2025年11月16日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
62
试验地点
1
主要终点
To compare intrathecal bupivacaine and dexmedetomidine versus intrathecal levobupivacaine and dexmedetomidine in terms of onset and duration of sensory and motor block

研究概览

简要总结

patient fulfilling the inclusion criteria will be assessed spinal anesthesia will be given the mentioned parameters like  onset and duration of sensory  motor block  duration of analgesia hemodynamic parameter and any adverse effects will be assessed. dermatomes levels will be tested every 2 min and sensory level is noted. Time to two segment sensory regression will be recorded. The motor dermatome level will be assessed using Modified Bromage scale. The time to reach Bromage scale 3 before surgery and Bromage 0 in post anaesthesia care unit (PACU) will be recorded On achieving adequate sensory blockade level surgery will be allowed.Hemodynamic monitoring including SBP and DBP mean arterial pressure,heart rate and peripheral oxygen saturation level will be recorded intra and postoperation as follow at the baseline values (before block)immediately after block during the operation at 5, 10, 15,20,25, 30, and 60 min after spinal block, at the end of the procedure and every 60 min in the recovery room.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator 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

  • patient willing to participate in study and provide informed consent.
  • ASA physical status 1 and
  • age between 18 to 60 years patient posted for surgery under spinal anaesthesia.

排除标准

  • participants with history of allergy to study drugs.
  • participants with bleeding disorders, uncontrolled diabetic mellitus, cardiovascular, renal and liver disorders.
  • local site infection, peripheral vascular disease.
  • patients with pyschiatric disorder and on antipsychotic medications.
  • pregnant women.

结局指标

主要结局

To compare intrathecal bupivacaine and dexmedetomidine versus intrathecal levobupivacaine and dexmedetomidine in terms of onset and duration of sensory and motor block

时间窗: dermatomes levels will be | tested every 2 min and sensory level is noted. Time to two segment sensory regression | will be recorded. The motor dermatome level will be assessed using Modified | Bromage scale. The time to reach Bromage scale 3 before surgery and Bromage 0 in | post anaesthesia care unit (PACU) will be recorded.

次要结局

  • To compare two drugs in terms of duration of analgesia hemodynamic parameter and any adverse effects(immediately after)

研究者

发起方
sapthagiri institute of medical science and research center
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

V Loka Priya

sapthagiri institute of medical sciences and research center

研究点 (1)

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