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Comparison of effect of two drugs (phenylephrine and norepinephrine) administered to maintain blood pressure in pregnant patients undergoing caesarean section under spinal anaesthesia on the mother and the newborn

A comparison of efficacy of prophylactic infusion of Phenylephrine versus Norepinephrine for the prevention of post spinal hypotension in parturients undergoing elective caesarean section- A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/06/008915
Enrollment
130
Registered
2017-06-27
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- WOMEN UNDERGOING ELECTIVE CAESAREAN SECTION

Interventions

Intervention1: NOREPINEPHRINE: INFUSION 5mcg/min at 2.5 ml/min (i.e. 2mcg/ml). Control Intervention1: PHENYLEPHRINE: INFUSION 25mcg/min at 2.5ml/min (i.e. 10mcg/ml)

Sponsors

ALL INDIA INSTITUTE OF MEDICAL SCIENCES
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. WOMEN OF SINGLETON PREGNANCY WITH GESTATIONAL AGE OF MORE THAN 36 WEEKS OF GESTATION 2. ASA I AND II WOMEN

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2. Multiple gestation 3. Pregnancy with severe systemic illness (uncontrolled diabetes, hypertension, cardiac disease, etc.) 4. BMI > 40 kg/m2 5. In active labour 6. Suspected obstetric complications ( like polyhydraminos, IUGR) 7. Patients in whom spinal anaesthesia is contraindicated (spinal abnormalities, infection at the site of injection, coagulopathies, raised intracranial tension)

Design outcomes

Primary

MeasureTime frame
To compare the incidence and severity of hypotension, following prophylactic infusion of phenylephrine and norepinephrine in parturients undergoing LSCS under spinal anaesthesiaTimepoint: In the period between administration of spinal anaesthesia and upto the skin closure

Secondary

MeasureTime frame
Occurrence of maternal bradycardia, reactive hypertension, total rescue vasopressor requirement, neonatal acid-base status and APGAR scoresTimepoint: during the surgery and immediate postpartum period

Countries

India

Contacts

Public ContactBANUPRIYA

ALL INDIA INSTITUTE OF MEDICAL SCIENCES

drsrajeshwari@gmail.com9677629587

Outcome results

None listed

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