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临床试验/CTRI/2024/05/067647
CTRI/2024/05/067647招募中4 期

A Comparative study to evaluate the clinical efficacy of Subarachnoid block using Hyperbaric Levobupivacine 0.5% Versus Hyperbaric Ropivacaine 0.75% for elective infraumblical surgeries

Chamarajanagar Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年1月7日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
To evaluate and compare the onset of sensory and motor block characteristics and duration of sensory and motor block among the two study drugs

研究概览

简要总结

Subarachnoid block (SAB) is the most widely used anaesthetic technique for infraumblical surgeries providing a faster, reliable onset,with safe and effective sensory and motor blockade. Hyperbaric local anaesthetic solutions are more predictable with reliable intrathecal spread and less interpatient variability.

Hyperbaric Levobupivacaine is preferred because they produce effective sensory and motor block compared to isobaric preparations and has an added advantage of adjusting the level of block. During literature survey,we could find only few direct comparison between hyperbaric Levobupivacaine and Ropivacaine as they are recently introduced.Hence we wanted to evaluate and compare the block characteristics in terms of sensory,motor characteristics and hemodynamic changes and complications if any.

研究设计

研究类型
Interventional
分配方式
Random Number Table
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 wiiling to give written informed consent -Patients belonging to American Society of Anaesthesiologist physical status class 1 and 2 of either sex.
  • Patient with age group between 18 to 65 years posted for elective infraumblical surgeries.

排除标准

  • 1.Patients with coagulation disorders or on anticoagulants.
  • 2.Any other contraindications for spinal anaesthesia.
  • 3.Patients with spinal deformity,infection at the site of the procedure.

结局指标

主要结局

To evaluate and compare the onset of sensory and motor block characteristics and duration of sensory and motor block among the two study drugs

时间窗: 2 hours

次要结局

  • To study hemodynamic characteristics between the two drugs(To assess the complications/side effects among the drugs.)

研究者

发起方
Chamarajanagar Institute of Medical Sciences
申办方类型
Government medical college

研究点 (1)

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