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comparison of drugs to prevent hypotension (fall in blood pressure)

Comparison of ephedrine and phenylephrine for prevention of spinal induced hypotension in cesarean section: A prospective randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031358
Enrollment
60
Registered
2021-02-17
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: O749- Complication of anesthesia duringlabor and delivery, unspecified

Interventions

Intervention1: ephedrine 3mg/ml: Dose: ephedrine 3mg/ml Route of administration: IV Control Intervention1: phenylephrine 100μg/ml: Dose: phenylephrine 100μg/ml Route of administration: IV

Sponsors

Dr Aman Malawat
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA grade I & II 2. Planned for elective lower segment caesarean section with a singleton fetus & pregnancy at term 3. Age equal to more than18 years 4. Weight between 40-80 kgs. 5. 150cm â?? 180 cm tall

Exclusion criteria

Exclusion criteria: 1. Parturients with maternal cardiac disease 2. Parturients with maternal haematological disease 3. Parturients with diabetes 4. Parturients with eclampsia 5. Parturients with bleeding or coagulation test abnormalities 6. Parturients with fetal distress 7. Parturients with known fetal anomalies 8. Patients with known sensitivity to any of drug used 9. Patients with compromised renal, cardiac and respiratory status like asthma, recent MI, conduction disturbances, CVA, severe coronary insufficiency, chronic renal insufficiency. 10. Patients on antihypertensive medication

Design outcomes

Primary

MeasureTime frame
To assess and compare haemodynamic changes intraoperatively intravenous infusion of ephedrine and phenylephrine in spinal anaesthesia.Timepoint: baseline—

Secondary

MeasureTime frame
To compare the efficacy of prophylactic intravenous infusion of ephedrine and phenylephrine in preventing incidence of spinal hypotension during elective caesarean section.Timepoint: baseline;To compare the maternal haemodynamic parameters of blood pressure and heart rate during the two infusions.Timepoint: baseline;To evaluate and compare the neonatal outcome by measuring APGAR scores. Timepoint: baseline;To observe the occurrence of side effects (nausea, vomiting, bradycardia, etc)Timepoint: baseline—

Countries

India

Contacts

Public ContactDr Durga Jethava

Mahatma Gandhi Medical College and Hospital, Jaipur

dr.a.malawat@gmail.com7737200883

Outcome results

None listed

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