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临床试验/CTRI/2025/04/085023
CTRI/2025/04/085023尚未招募2 期

Prospective Randomized double blind comparitive study between the efficacy of intrathecal 0.5 percent Bupivacaine heavy vs isobaric in elective lscs.

dy patil school of medicine and hospital nerul navi mumbai1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
48
试验地点
1
主要终点
To compare the anaesthetic properties of isobaric and hyperbaric

研究概览

简要总结

Elective lower segment cesarian section is a commonly performed surgical procedure which requires anaesthesia. Most common mode of anaesthesia used is spinal anaesthesia . The drug commonly used to give spinal anaesthesia in such patients is injection bupivacaine 0.5 percent hyperbaric. This study aims to compare the anaesthetic properties and haemodynamic changes caused by the aforementioned drug to isobaric injection bupivacaine 0.5 and its anaesthetic properties and haemodynamic changes.

Inclusion criteria includes patients undergoing elective cesarian section between the ages of 20 and 40. ASA 2. Height more than 150 cms and gestational age of greater than 35 weeks.

Similarly exclusion criteria involves patients undergoing emergency lower section cesarean section , contraindication or allergy to the above used drugs, contraindication to spinal anaesthesia, patient refusal.

The study will be conducted in dy patil school of medicine and hospital, nerul, navi mumbai. Over a period of 2 years.

The study method is randomised control trial double blind.

Sample size is 48.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • 1 All patients giving consent undergoing elective lscs 2 ASA grade 2 3 patients coming for elective c-section with gestational age og greater than 35 weeks 4 height more than 150 cms.

排除标准

  • Patients undergoing emergency C-SECTIONS 1 Patients known or suspected to have allergy for study drugs.
  • 2 Patient refusal 3 Patients with contraindications to spinal anaesthesia.

结局指标

主要结局

To compare the anaesthetic properties of isobaric and hyperbaric

时间窗: at base line,2 mins,4 mins, 6 mins, 8 mins, 15 mins, 20 mins, 25 mins, 30 mins, 40 mins, 50 mins, 60 mins

bupivacaine in spinal anaesthesia, which includes the time of onset of sensory

时间窗: at base line,2 mins,4 mins, 6 mins, 8 mins, 15 mins, 20 mins, 25 mins, 30 mins, 40 mins, 50 mins, 60 mins

and motor block and duration of block obtained (both sensory and motor)

时间窗: at base line,2 mins,4 mins, 6 mins, 8 mins, 15 mins, 20 mins, 25 mins, 30 mins, 40 mins, 50 mins, 60 mins

次要结局

  • To compare the effects of both the drugs on haemodynamic(parameters which include heart rate & blood pressure & side effects.)

研究者

发起方
dy patil school of medicine and hospital nerul navi mumbai
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr kaushik dandanak

D.Y Patil school of medicine

研究点 (1)

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