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临床试验/CTRI/2023/08/057012
CTRI/2023/08/057012尚未招募3 期

Prospective randomised double blinded interventional study to compare the dose of ephedrine required to control hypotension in patients receiving two different doses of ondansetron during elective caesarean section under spinal anaesthesia :At SMS Medical College, Jaipur

Department of Anaesthesiology, SMS Medical College and attached Hospitals, Jaipur1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年4月9日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
1)To determine the difference in total dose of ephedrine required to control hypotension between two different doses of intravenous ondansetron in parturients undergoing elective lower segment caesarean section .

研究概览

简要总结

The aim of this study is to compare the efficacy of two different dose of intravenous ondansetron in preventing the hypotension after spinal anaesthesia by calculating the total dose of ephedrine required to control hypotension in patients undergoing elective caesarean section. In this study two different doses of intravenous ondansetron 4mg and 8mg will be given 5 minutes before spinal anaesthesia . Total dose of ephedrine required to control hypotension will be calculated in both groups. This will help us to know the effective dose of ondansetron to prevent hypotension in LSCS cases under spinal anaesthesia.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Patients undergoing elective caesarean section.
  • Age between 18-35 years.
  • Patients belonging to American Society Of Anaesthesiologist(ASA) grade II.
  • Patients consenting to participate.

排除标准

  • History of pre eclampsia and eclampsia.
  • Obesity 3)Patients with allergy to drugs used in the study.
  • Patients with contraindication to neuraxial anaesthesia.
  • Patients with history of drug abuse or addictions.

结局指标

主要结局

1)To determine the difference in total dose of ephedrine required to control hypotension between two different doses of intravenous ondansetron in parturients undergoing elective lower segment caesarean section .

时间窗: Baseline | 00 minutes(after spinal) | 01 minutes | 02 minutes | 03 minutes | 05 minutes | 10 minutes | 15 minutes | 20 minutes | 25 minutes | 30 minutes | 40 minutes | 50 minutes | 60 minutes

2)To determine the difference in proportion of hypotension between two different doses of intravenous ondansetron in parturients undergoing elective lower segment caesarean section.

时间窗: Baseline | 00 minutes(after spinal) | 01 minutes | 02 minutes | 03 minutes | 05 minutes | 10 minutes | 15 minutes | 20 minutes | 25 minutes | 30 minutes | 40 minutes | 50 minutes | 60 minutes

次要结局

  • To determine side effects between both groups -Nausea, Vomiting, shivering, bradycardia(The application of spinal anaesthesia till completion of surgery.)

研究者

发起方
Department of Anaesthesiology, SMS Medical College and attached Hospitals, Jaipur
申办方类型
Government medical college

研究点 (1)

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