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Prevention of low blood pressure in pregnant women undergoing caesarean delivery

Comparison of nebulised Phenylephrine and nebulised Norepinephrine for prevention of Post Spinal Hypotension in patients undergoing Elective Caesarean delivery: A double blind, Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079503
Enrollment
99
Registered
2025-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium

Interventions

Intervention1: Nebulization with Phenylephrine: Ultrasonic nebulization of 200 mcg phenylephrine diluted in 4 ml solution
i.e. (50 mcg/ml) at the rate of 12.5 mcg/min till the delivery of fetus Intervention2: Nebulization with Norepinephrine: Ultrasonic nebulisation of 40 mcg norepinephrine in 4 ml solution (10 mcg/ml) a

Sponsors

All India institute of medical sciences, Patna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women undergoing elective caesarean section under spinal anaesthesia.

Exclusion criteria

Exclusion criteria: Patient refusal, Patient Allergic or hypersensitive to phenylephrine or norepinephrine, Preterm pregnancy, Twin pregnancy, ASA III, IV patient, Preeclamptic patient, Patient undergoing emergency caesarean section

Design outcomes

Primary

MeasureTime frame
Incidence of Post spinal hypotension after receiving prophylactic nebulised dose of phenylephrine and norepinephrine in patient undergoing elective caesarean sectionTimepoint: Till the end of the operation

Secondary

MeasureTime frame
Neonatal APGAR scoreTimepoint: At 1 mins, 5 mins; Any change in neonatal umbilical venous sampling for blood gas analysis.Timepoint: Just after delivery; Requirement of IV bolus dose of Phenylephrine (50 mcg)Timepoint: During caesarean section; Total volume of crystalloids (ml)Timepoint: During caesarean section; Any adverse events like nausea, vomiting and shiveringTimepoint: During caesarean section; Incidence of reflex bradycardiaTimepoint: During caesarean section

Countries

India

Contacts

Public ContactNeeraj Kumar

All India institute of medical sciences Patna

neeraj.jlnmc@gmail.com8210104972

Outcome results

None listed

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