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临床试验/CTRI/2025/02/080915
CTRI/2025/02/080915尚未招募1/2 期

A COMPARATIVE STUDY OF HYPERBARIC BUPIVACAINE 0.5 percent V/S HYPERBARIC LEVOBUPIVACAINE 0.5 percent IN SPINAL ANAESTHESIA FOR LOWER ABDOMINAL AND LOWER EXTERMITY SURGERIES

Dr sandhya singh1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月28日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To explore the dose-response relationship

研究概览

简要总结

Spinal anesthesia is a widely used technique for regional anesthesia, offering advantages such as rapid onset, patient wakefulness, minimal side effects, and reduced need for airway manipulation. It is especially preferred for lower abdominal and lower extremity surgeries due to its effective sensory and motor blockade, quick action, and lower risk of complications like thromboembolic events.

Bupivacaine, a commonly used anesthetic, has both dextro- and levo-isomers. The dextro-isomer is associated with higher cardiotoxicity, prompting the development of levobupivacaine (the S-isomer), which has lower cardiovascular and CNS toxicity while maintaining similar analgesic efficacy. Levobupivacaine tends to produce a more prolonged sensory and motor blockade compared to racemic bupivacaine.

This study aims to compare the effects of hyperbaric bupivacaine 0.5% versus hyperbaric levobupivacaine 0.5% in spinal anesthesia for lower abdominal and lower extremity surgeries.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

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

入选标准

  • American society of Anaesthesiologist (ASA) physical status I/II Planned for elective surgery under Spinal anaesthesia.

排除标准

  • Patients refusing consent Patients having local sepsis at site where spinal anesthesia is to given.
  • Patients with known bleeding or coagulation disorders Patients with spinal deformity Patients with Cardiopulmonary diseases Patients with Neurological or psychiatric disorders.

结局指标

主要结局

To explore the dose-response relationship

时间窗: Every 3 min for 15 min then every 15 min till | recovery

between hyperbaric

时间窗: Every 3 min for 15 min then every 15 min till | recovery

bupivacaine and hyperbaric levobupivaciane regarding anaesthesia quality and

时间窗: Every 3 min for 15 min then every 15 min till | recovery

duration

时间窗: Every 3 min for 15 min then every 15 min till | recovery

次要结局

  • To identify any potential predictors of optimal(dose selection based on)

研究者

发起方
Dr sandhya singh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sandhya singh

Varun Arjun Medical College and Rohilkhand Hospital

研究点 (1)

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