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To compare the effects of drugs phenylephrine and noradrenaline on newborn babies when used for fall in blood pressure after spinal anaesthesia in Caeserean delivery

Comparison of effect of phenylephrine and noradrenaline boluses used for postspinal hypotension on neonatal outcome in elective caeserean section

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/026239
Enrollment
100
Registered
2020-06-30
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: O754- Other complications of obstetric surgery and procedures

Interventions

Intervention1: Injection Noradrenaline Bitartrate: Injection Noradrenaline Bitartrate,intravenous,as 5 micrograms per ml.1ml of the drug given as boluses to treat each systolic blood pressure reading

Sponsors

Dr Prerona Saha
Lead Sponsor
Dr Chandita Konwar
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients willing to participate in the study 2.American Society of Anaesthesiologists physical status 2 3.Women with uncomplicated singleton pregnancy scheduled for elective caeserean section under spinal anaesthesia 4.Women aged 18years and more

Exclusion criteria

Exclusion criteria: 1.Women not developing post-spinal hypotension(defined as 20% or more decline in sysytolic arterial pressure from baseline value or absolute value of less than 100 mm Hg) 2.Women with medical conditions(diabetes,hypertensive diseases or pre-eclampsia,cardiovascular diseases,cerebrovascular diseases,renal impairment) 3.Patients having placenta praevia 4.Parturients with fetal malformations 5.On prolonged drug therapy like monoamine oxidase inhibitors,tricyclic anti-depressants 6.Systolic arterial pressure less than 100mm Hg 7.Estimated fetal weight less than 2.5kg or more than 4.5kg 8.Women with height and weight less than 10% or more than 95% for respective age

Design outcomes

Primary

MeasureTime frame
To compare the effect of bolus doses of phenylephrine and noradrenaline on umbilical cord blood pHTimepoint: At delivery of the baby before the first cry

Secondary

MeasureTime frame
APGAR score of the babyTimepoint: at 1minute and 5minutes;Changes in maternal heart rate,systolic arterial pressure and mean arterial pressureTimepoint: After subarachnoid block every 3minutes till the delivery of baby;Incidence of maternal complications-Nausea,vomiting,chest discomfortTimepoint: from administration of drug till the end of surgery

Countries

India

Contacts

Public ContactDr Chandita Konwar

Gauhati Medical College and Hospital

chandita3715@yahoo.co.in9864063213

Outcome results

None listed

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