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临床试验/CTRI/2024/06/069129
CTRI/2024/06/069129尚未招募2/3 期

Comparision of prophylactic infusion of Phenylephrine versus Norepinephrine for the prevention of post spinal hypotension in parturients undergoing elective caesaeran section-A double blinded, non inferiority, randomised controlled trial

Department of Anaesthesia1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年6月24日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
80
试验地点
1
主要终点
To measure proportion of hypotension between 2 groups

研究概览

简要总结

Spinal anaesthesia is the technique of choice for elective caesarean delivery; however this technique results in hypotension in the vast majority of women if not actively prevented. The consequences of spinal hypotension in this setting are proportional to the severity and include nausea and vomiting, decrease in uteroplacental blood flow, fetal acidosis, and rarely, cardiovascular collapse. Without prophylactic Vasopressors, post spinal hypotension affects neatly 60% of women during caesarean delivery; thus using vasopressors have been highly recommended for routine prevention of post spinal hypotension during caesarean delivery. Phenylephrine is a potent α -adrenergic receptor agonist as emerged as the vasopressor of choice for management of post spinal hypotension. It’s use is often associated with a dose related reflexive slowing of maternal heart rate(HR) and a corresponding decrease in cardiac output(CO).Although the clinical significance of these decreases in HR and CO in healthy patients with unstressed fetuses is unknown, concern has been expressed that there may be potential for harm in the presence of a compromised fetus. Hence the use of norepinephrine which is characterized by α -adrenergic agonistic activity in addition to a weak β -adrenergic agonistic activity, is recommended as vasopressor with minimal cardiac depressant effect to prevent maternal hypotension. These pharmacologic properties would make norepinephrine an attractive alternative to phenylephrine and ephedrine in obstetric anaesthesia. We postulated that norepinephrine might therefore be an effective vasopressor for maintaining blood pressure during spinal anaesthesia with less tendency to decrease Heart rate and Cardiac output.

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • American Society of Anaesthesiologist grade Non labouring,normotensive parturients Term singleton pregnancy Posted for Elective caesarean section under Spinal anaesthesia.

排除标准

  • Known fetal abnormality, Pre existing or pregnancy-induced hypertension, Known cardiovascular or cerebrovascular disease, Allergy or hypersensitivity to study drugs Thrombocytopenia, coagulopathy, or any medical contraindication to spinal anaesthesia Weight-50-100kg Height-140 or 180cm Patients who refused to give consent.

结局指标

主要结局

To measure proportion of hypotension between 2 groups

时间窗: 1 hour

次要结局

  • Secondary objectives - incidence of maternal bradycardia, nausea and vomiting, reactive hypertension, requirement of rescue boluses of vasopressor and atropine between the 2 groups.(1 hour)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

DrAnil Kumar Ganeshnavar

S.Nijalingappa Medical College

研究点 (1)

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