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临床试验/CTRI/2024/10/075003
CTRI/2024/10/075003尚未招募3 期

a comparative study of prophylactic norepinephrine and phenylephrine infusion for controlling spinal anaesthesia induced hypotension in parturients undergoing lower section caesarean section-randomized clinical trial

Joydeepa Das1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2024年10月9日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
104
试验地点
1
主要终点
occurence of hypotension

研究概览

简要总结

Spinal anaesthesia is the most commonly preferred type of anaesthesia in elective cesarean section. But hypotension following spinal anaesthesia is a common and dreadful complication. The use of nonpharmacological methods is not found to be effective, hence use of vasopressor is indicated in the management of hypotension. Among vasopressors norepinephrine and phenylephrine are used.

Here, in our study, we will compare the infusion doses of two drugs to prevent spinal anesthesia-induced hypotension. We will also try to find out the vasopressor (phenylephrine or norepinephrine) that brings the most stable hemodynamic response and least adverse reactions.

A total of 104 parturients, aged 18 to 45 years belonging to the American Society of Anaesthesiologists (ASA) I and II, undergoing lower segment caesarean section under spinal anaesthesia will be divided into two groups (Group A and Group B) by block randomization. Group A patients will receive norepinephrine 60ml/hr as intravenous infusion, group B patients will receive phenylephrine 60ml/hr as intravenous infusion, after subarachnoid block at the rate of 1ml/kg/hr. The number of occurrences of hypotension (before delivery and after delivery) will be noted. Hemodynamic parameters will be monitored and recorded. The baseline values will be compared with the values obtained after spinal block in all four groups. The incidence of bradycardia, hypertension, and fetal outcomes such as Apgar score and umbilical vein blood gases will also be recorded.

The findings and observations made during the entire study will be tabulated, graphically depicted whenever possible, statistically analyzed and inference will be drawn.

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 45.00 Year(s)(—)
性别
Female

入选标准

  • Patients of age group 18 to 45 years undergoing elective caesarean section Patients with American Society of Anaesthesiologists (ASA) physical grade I or II.

排除标准

  • history of allergy to local anesthetic drug and study drugs local site infection spinal deformity parturients with PET or any hypertensive disorder bleeding disorders cardiac, respiratory diseases, kidney disorders, neurological deficit.

结局指标

主要结局

occurence of hypotension

时间窗: outcome will be continuosly recorded every 2 mins till 10mins then every 5 mins until the end of surgery and data will be assessed at the end of one year

次要结局

  • Apgar score, umbilical vein blood gases record, hemodynamic changes, norepinephrine consumption, adverse effects(all outcomes will be continuously recorded every 2 mins till 10 mins and then every 5 mins until the end of surgery)

研究者

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

Joydeepa Das

Regional Institute of Medical Sciences

研究点 (1)

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