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临床试验/CTRI/2016/12/007541
CTRI/2016/12/007541已完成4 期

Randomized double blind comparison of phenylephrine and norepinephrine boluses for treatment of post-spinal hypotension during elective caesarean section

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 90 人开始时间: 2016年9月12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
90
试验地点
1
主要终点
incidence of maternal bradycardia (HR less than 60)

研究概览

简要总结

This study is a randomized, double blind, parallel group trial comparing phenylephrine and norepinephrine for the treatment of post-spinal hypotension in patients undergoing elective caesarean section. Post-spinal hypotension, defined as fall of SBP 20% or more from the baseline or an absolute SBP less than100 mm Hg, whichever is higher; will be treated with inj. phenylephrine 100 microg iv or inj. norepinephrine 5 microg iv. Umbilical arterial and venous blood samples of the fetus will be obtained from a segment of umbilical cord double clamped before the baby’s first breath for blood gas analysis. The primary outcome measure will be incidence of maternal bradycardia (HR  below 60 per minute). The secondary outcome measures will be change in maternal SBP, number of episodes of hypotension, total vasopressor doses given, Apgar scores at 1 and 5 minutes, incidence of fetal acidosis (defined as umbilical artery pH  less than 7.20), incidence of tachycardia/bradycardia/ arrhythmias/hypertension, incidence of nausea, vomiting, dizziness or any other complications.

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
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Healthy females with term, uncomplicated, singleton pregnancy undergoing elective caesarean section under spinal anaesthesia.

排除标准

  • •Maternal complications e.g. diabetes, pre-eclampsia, cardiovascular disease, cerebrovascular disease, renal impairment •Placental complications viz., placenta praevia or abruptio placentae •Cord complications viz., nuchal cord or cord prolapse •Fetal malformations •Multiple gestation •Patients with absolute or relative contra-indications for spinal anaesthesia e.g. infection in lumbar area, coagulation abnormalities, autonomic neuropathy, spinal deformities, other neurological diseases, hypovolemia due to any cause •Patients on monoamine oxidase inhibitors or tricyclic antidepressants •Presence of mesenteric or peripheral vascular thrombosis •Maternal baseline SBP less than 100 mmHg •Patients with baby birth weight less than 2.5 kg or greater than 4.5 kg.

结局指标

主要结局

incidence of maternal bradycardia (HR less than 60)

时间窗: till delivery of baby

次要结局

  • •Changes in maternal SBP after vasopressor administration(•Number of episodes of hypotension)

研究者

发起方
University College of Medical Sciences and Guru Teg Bahadur Hospital
申办方类型
Government medical college

研究点 (1)

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