CTRI/2023/08/056746尚未招募Phase 3 4
A comparative study to assess the efficacy of combination of Glycopyrrolate, Ondansetron and Ephedrine in prevention of hypotension following obstetric spinal anaesthsia in terms of need for therapeutic dose of Ephedrine- a randomized, double blind, controlled study in Department of Anaesthesiology, SMS Medical College, Jaipur.
Sawai Man Singh Medical College Jaipur1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年8月25日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1. Mean total dose of ephedrine required intra operatively in both the groups.
研究概览
简要总结
Hypotension is one of the major complications following spinal anaesthesia in caeserean sections which may compromise the well-being of both the mother and the newborn. Our aim is to find out whether prophylactic combination of Glycopyrrolate, Ondansetron and Ephedrine is effective in minimizing hypotension following obstetric spinal anaesthesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Parturients aged 20-35 years.
- •parturients belong to ASA Grade I and II
- •Parturients undergoing elective caeserean section under spinal anaesthesia.
- •Parturients willing to participate in the study.
排除标准
- •Parturients with contraindications to spinal anaesthesia.
- •Parturients with history of allergy to study drugs.
- •Parturients with pregnancy induced hypertention
- •Parturients with multiple gestations and abnormal placentation.
- •Parturients with height less than 145cm.
结局指标
主要结局
1. Mean total dose of ephedrine required intra operatively in both the groups.
时间窗: 90 minutes
2. Mean number of hypotension episodes between the period of induction & delivery of baby in both the groups.
时间窗: 90 minutes
3. Mean number of bradycardia episodes in intra operative period in both the groups.
时间窗: 90 minutes
次要结局
- 1. Neonatal APGAR scores at 0 & 3min.(2. Delivery time in both the groups.)
研究者
研究点 (1)
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