A clinical trial to study the effects of two drugs, phenylephrine and norepinephrine, for treatment of low blood pressure in patients undergoing Caesarean operation.

Active, not recruiting

• Conditions: Other complications of spinal andepidural anesthesia during pregnancy,

• Registration Number: CTRI/2017/12/010829
• Lead Sponsor: Safdarjung Hospital

Brief Summary

Spinal anaesthesia, technique of choice for Caesarean delivery, is associated with hypotension. Hypotension should be treated rapidly by administrationof vasoactive drugs. Phenylephrine, a α-adrenergic drug, is currentlythe vasopressor of choice for prevention and management of post spinalhypotension. However, phenylephrine has a dose-related tendency to decrease heartrate and cardiac output. Norepinephrine is a potent α-adrenergic receptoragonist, but unlike phenylephrine, it is also a relatively weak agonist atβ-adrenergic receptors. The study hypothesis isthat norepinephrine is a superior vasopressor as compared to phenylephrine fortreatment of post spinal hypotension in Caesarean delivery in terms of maternaland neonatal outcome. The aim of the present study is to compare the effect ofnorepinephrine and phenylephrine for treatment of maternal hypotension duringspinal anaesthesia in patients undergoing elective Caesarean delivery and tostudy the effects of these vasopressors on neonatal outcome (primary outcomemeasure).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-02
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• American Society of Anaesthesiologists physical status I and II women 2.
• Term pregnancy 3.
• Singleton pregnancy 4.
• Scheduled for elective Caesarean delivery under spinal anaesthesia.

Exclusion Criteria

• Pre-existing or pregnancy induced hypertension 2.
• Diabetes Mellitus 3.
• Known cardiovascular or cerebrovascular disease 4.
• Foetal abnormality 5.
• Onset of labour 6.
• Allergy to any study medication 7.
• Weight less than 50 kg or more than 100 kg.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of bolus administration of phenylephrine and norepinephrine for treatment of post spinal hypotension on neonatal outcome by umbilical cord blood gas analysis	At time of delivery of baby

Secondary Outcome Measures

Name	Time	Method
1. To evaluate and compare the effect of bolus administration of phenylephrine and norepinephrine for treatment of post spinal hypotension in patients undergoing elective Caesarean delivery (maternal outcome).	2. To evaluate the effect of bolus administration of PE and NE on neonatal outcome on Apgar scores and neurobehavioral response evaluation.

Trial Locations

Locations (1)

Vardhmaan Mahavir Medical College and Safdarjung Hospital; 🇮🇳 South, DELHI, India

Vardhmaan Mahavir Medical College and Safdarjung Hospital

🇮🇳South, DELHI, India

Akshatha V Rai

Principal investigator

9008821398

akshatharai3@gmail.com