Comparison of phenylephrine and norepinephrine boluses for treatment of fall in blood pressure during planned caesarean section under spinal anaesthesia

Phase 4

Completed

• Conditions: Spinal Anaesthesia induced Hypotension in Elective caesarean section

• Registration Number: CTRI/2016/12/007541
• Lead Sponsor: University College of Medical Sciences and Guru Teg Bahadur Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-12
• Study Completion: 2018-01-23
• Last Update Posted: 2018-05-16

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

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

Exclusion Criteria

•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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of maternal bradycardia (HR less than 60)	till delivery of baby

Secondary Outcome Measures

Name	Time	Method
•Changes in maternal SBP after vasopressor administration	•Number of episodes of hypotension

Trial Locations

Locations (1)

University College of Medical Sciences and GTB Hospital; 🇮🇳 East, DELHI, India

University College of Medical Sciences and GTB Hospital

🇮🇳East, DELHI, India

Dr Medha Mohta

Principal investigator

9868399626

medhamohta@hotmail.com