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临床试验/CTRI/2023/08/056895
CTRI/2023/08/056895招募中3 期

Comparision of 0.75% intrathecal hyperbaric ropivacaine, 0.5% hyperbaric levo-bupivacaine, and 0.5% hyperbaric bupivacaine with fentanyl 25mcg as common adjuvant to all three groups in lower abdominal surgeries

Department of Anesthesiology1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年1月9日最近更新:

试验速览

阶段
3 期
状态
招募中
入组人数
90
试验地点
1
主要终点
Determine the onset of sensory & motor blockade

研究概览

简要总结

Comparision of 0.75% intrathecal hyperbaric ropivacaine, 0.5% hyperbaric levo-bupivacaine, and 0.5% hyperbaric bupivacaine with fentanyl 25mcg as common adjuvant to all three groups in lower abdominal surgeries. Compaing the time of onset of sensory and motor blockade. And also to compare the duration of sensory and motor blockade and the time of first rescue analgesia required by the patient. Toxicity profile of three drugs are also studied in this trail.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Double Blind Double Dummy

入排标准

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

入选标准

  • 1.Age more than 18years and less than 60 years 2.ASA Grade I and II patietns 3.Patient giving valid informed consent.
  • 4.Lower Abdominal surgeries taken under only spinal anaesthesia
  • Both male and female patients.

排除标准

  • 1.age more than 60 years and less than 18 years 2.ASA grade 3 &
  • 3.Patient refusal.
  • 4.Patients with local infection at puncturing site.
  • 5.Patients with Ischemic and Rheumatic heart diseases.
  • 6.Patients with coagulation defects and patients on anticoagulants.
  • 7.Patients allergic to local anesthetic drugs.
  • Surgeries converted to general anaesthesia.

结局指标

主要结局

Determine the onset of sensory & motor blockade

时间窗: At Baseline

次要结局

  • Duration of motor blockade & oveall hemodynamic changes(After 3 hours)

研究者

申办方类型
Private medical college

研究点 (1)

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