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

Comparison of phenylephrine and norepinephrine for treatment of spinal hypotension during elective caesarean delivery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/12/010829
Enrollment
90
Registered
2017-12-11
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: O295- Other complications of spinal andepidural anesthesia during pregnancy

Interventions

Intervention1: Norepinephrine: Norepinephrine intravenous bolus will be given whenever patient blood pressure decreases more than 20 percent of baseline Control Intervention1: Phenylephrine: Phenyleph

Sponsors

Safdarjung Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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

Exclusion criteria: 1. 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

Design outcomes

Primary

MeasureTime frame
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 analysisTimepoint: At time of delivery of baby—

Secondary

MeasureTime frame
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. Timepoint: Blood pressure: Every 2 min during surgery till delivery of baby Apgar Score: 1, 5 and 10 min after delivery of baby Neurobehavioral scores: 2-4h, 24 h and 48 h after delivery—

Countries

India

Contacts

Public ContactSmita Prakash

Vardhmaan Mahavir Medical College and Safdarjung Hospital, New Delhi

drsunilprakash@gmail.com9810347125

Outcome results

None listed

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