CTRI/2024/05/066927已完成4 期
Comparison of a modified regimen of prophylactic phenylephrine boluses versus variable rate infusion during elective caesarean section under spinal anaesthesia: a non-inferiority randomised double-blind study
University College of Medical Sciences and Guru Teg Bahadur Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年5月18日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of physician interventions
研究概览
简要总结
| 80 healthy mothers with term, uncomplicated, singleton pregnancy scheduled to undergo elective caesarean section under spinal anaesthesia will be given either prophylactic intravenous variable rate infusion of phenylephrine titrated according to systolic blood pressure or prophylactic bolus of phenylephrine immediately after spinal anaesthesia and then whenever systolic blood pressure falls to below 90% of baseline. Umbilical arterial and venous blood samples of the fetus will be obtained from a segment of umbilical cord for blood gas analysis. Primary outcome measure will be number of physician interventions. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Healthy mothers with term, uncomplicated, singleton pregnancy scheduled to undergo elective caesarean section under spinal anaesthesia.
排除标准
- •Maternal complications e.g., pre-eclampsia, cardiovascular disease, cerebrovascular disease, Multiple gestation, Placental complications, Known fetal abnormality, absolute or relative contra-indications for spinal anaesthesia.
结局指标
主要结局
Number of physician interventions
时间窗: delivery of baby
次要结局
- 1. Phenylephrine requirements(2. Number of episodes of hypotension, reactive hypertension, bradycardia or arrhythmias)
研究者
Dr Medha Mohta
University College Of Medical Sciences and Guru Teg Bahadur Hospital
研究点 (1)
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