跳至主要内容
临床试验/CTRI/2024/03/064194
CTRI/2024/03/064194尚未招募不适用

Norepinephrine versus ephedrine to maintain arterial blood pressure during spinal anaesthesia for cesarean delivery

Sms medical college2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年3月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
140
试验地点
2
主要终点
Mean arterial blood pressure. No.of rescue bolus of norepinephrine (5umg)and ephedrine (10mg)used,incidence of bradycardia/tachycardia, Neonatal Apgar score in both group

研究概览

简要总结

After the institutional ethics committee approved, after checking fasting status, informed consent and pac,I’ve access will be procedured. The baseline parameter, heart  rate ,oxygen saturation  ecg and arterial blood pressure will be recorded. Patient will be positioned in  sitting position, under all asceptic precautions Ths patient will be painted with providine iodine solution . then selected site will be draped with sterilized hole towel . Intervertebral space between L4-L5/L3-L4 intervertebral  space will be identified . A 25 G spinal needle is inserted on marked area after confirming free flow of clear CSF drug 12.5 milligrams of hyperbaric  bupivacaine 0.5% was injected and patient will be immediately placing supine position.

In group A prophylactic bolus of Norepinephrine 5mcg at time of intrathecal block plus rescue bolus of 5mcg Norepinephrine ,whenever maternal systolic blood pressure dropped by 20% of baseline value.

In group B prophylactic bolus of ephedrine 10mg at time of intrathecal block  plus rescue of 10mg ephedrine, whenever maternal systolic blood pressure dropped 20% of baseline value. Intra operative period ,blood pressure ( SBP, DBP,  MAP),Heart rate oxygen saturation noted at every 2 minutes till delivery of fetus and every 5 minutes delivery.

Neonatal outcome was assessed by APGAR score at first minut and five minut.

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
20.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Informed consent,age between 20_40year,patients undergoing elective cesarean section delivery,nondiabetic,non hypertensive,.

排除标准

  • Emergency cesarean section, Active labor, high risk pregnancy (intrauterine growth restrictions, pre eclampsia),maternal cardiovascular disease, chronic kidney and liver and pulmonary disease.

结局指标

主要结局

Mean arterial blood pressure. No.of rescue bolus of norepinephrine (5umg)and ephedrine (10mg)used,incidence of bradycardia/tachycardia, Neonatal Apgar score in both group

时间窗: Till given of subarchnoid block to compilations of surgery

次要结局

  • 1 Incidence of bradycardia/tachycardia . 2 Neonatal Apgar score in both group(After given subarchnoid block to compilation of surgery)

研究者

申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sarvesh Kumar yogi

Sms medical college jaipur

研究点 (2)

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