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

Randomized double blind comparison of phenylephrine and norepinephrine boluses for treatment of post-spinal hypotension during elective caesarean section

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/12/007541

Enrollment

Registered

2016-12-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Spinal Anaesthesia induced Hypotension in Elective caesarean section

Interventions

Intervention1: Group Norepinephrine: Norepinephrine 5 microg IV will be given for treatment of each hypotensive value of blood pressure till the time of delivery Control Intervention1: Group Phenyleph

Eligibility

Inclusion criteria

Inclusion criteria: Healthy females with term, uncomplicated, singleton pregnancy undergoing elective caesarean section under spinal anaesthesia

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
incidence of maternal bradycardia (HR less than 60)Timepoint: till delivery of baby	—

Secondary

Measure	Time frame
â?¢ Changes in maternal SBP after vasopressor administration â?¢ Number of episodes of hypotension â?¢ Total number of vasopressor doses given â?¢ Incidence of reactive hypertension and arrhythmias â?¢ Incidence of nausea, vomiting, dizziness or any other complications â?¢ Apgar scores at 1 and 5 minutes â?¢ Umbilical artery pH â?¢ Incidence of fetal acidosis, defined as umbilical artery pH less than 7.20Timepoint: till delivery of baby	—

Measure

Time frame

â?¢ Changes in maternal SBP after vasopressor administration â?¢ Number of episodes of hypotension â?¢ Total number of vasopressor doses given â?¢ Incidence of reactive hypertension and arrhythmias â?¢ Incidence of nausea, vomiting, dizziness or any other complications â?¢ Apgar scores at 1 and 5 minutes â?¢ Umbilical artery pH â?¢ Incidence of fetal acidosis, defined as umbilical artery pH less than 7.20Timepoint: till delivery of baby

—

Countries

India

Contacts

Public ContactDr Medha Mohta

University College of Medical Sciences and Guru Teg Bahadur Hospital

ankitagarg179@gmail.com9821183677

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026