跳至主要内容
临床试验/CTRI/2024/02/063340
CTRI/2024/02/063340尚未招募4 期

Comparison of efficacy of intrathecal bupivacaine heavy (0.5%) and levobupivacaine heavy (0.5%) for elective caesarean section

Anagha V Harlapur1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月4日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
The onset of action

研究概览

简要总结

Bupivacaine is the most commonly used drug for spinal anaesthesia. Plain Bupivacaine is hypobaric compared to CSF and is made heavy by addition of 8% glucose.

It is known to cause hypotension, bradycardia even sudden cardiac death. Levobupivacaine is pure enantiomer of bupivacaine and is truly isobaric with CSF of pregnant women. It causes less cardiotoxicity and is more specific for sensory blockade than motor blockade.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
Female

入选标准

  • Age 18-30 years ASA grading I and II Elective caesarean section surgical section.

排除标准

  • Patient who refused to give consent.
  • A Documented sensitivity to drug in the past.
  • Age less than 18 and more than
  • ASA grading III and IV.
  • Patient on anti hypertensive, anxiolytics, and anti epileptic.
  • Morbidly obese.
  • Patients for emergency lscs.
  • Patients with neurological and psychiatric illness.
  • Patients with spinal deformity.
  • Local site infections.

结局指标

主要结局

The onset of action

时间窗: Measured for half an hour every five minutes

Duration of sensory blockade

时间窗: Measured for half an hour every five minutes

Duration of motor blockade

时间窗: Measured for half an hour every five minutes

Quality of anaesthesia

时间窗: Measured for half an hour every five minutes

Hemodynamic alterations

时间窗: Measured for half an hour every five minutes

Adverse effects

时间窗: Measured for half an hour every five minutes

次要结局

  • Pruritus(Sedation)

研究者

发起方
Anagha V Harlapur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Anagha V Harlapur

BJGMC and Sassoon hospital

研究点 (1)

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