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To compare the effect of Coadministration of two different doses of injection of blood pressure raising medicines (phenylephrine) with uterine contractor (oxytocin) on the prevention of uterine contractor induced Reduction in blood pressure in caesarean delivery.

A prospective randomized double blind controlled study to compare the effect of coadministration of two different doses of intravenous phenylephrine with oxytocin on the prevention of oxytocin induced hypotension in lower segment caesarean section under subarachnoid block - Not applicable

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/042110
Enrollment
120
Registered
2022-04-25
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

Health Condition 1: O82- Encounter for cesarean delivery without indication Health Condition 2: O82- Encounter for cesarean delivery without indication

Interventions

Intervention1: Prevention of oxytocin Induced Hypotension during Lower segment caesarean section by Phenylephrine: prevention of Oxytocin induced hypotension by injection phenylephrine dose 50mcg intr

Sponsors

Department of Anaesthesiology SMS Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA II Parturient undergoing lower segment caesarean section under subarachnoid block.

Exclusion criteria

Exclusion criteria: ASA III, IV and V parturient Uncontrolled pregnancy induced hypertension, preeclampsia eclampsia,history of allergic reaction to local anaesthetic or drugs, skin infection of local site or gross spinal abnormalities, Blood coagulopathies, haemorrhagic diathesis Renal and hepatic impairment.

Design outcomes

Primary

MeasureTime frame
To compare the effectiveness of coadministration of two different doses of intravenous phenylephrine with oxytocin on the prevention of oxytocin-induced hypotension in lower segment caesarean section cases under subarachnoid block.Timepoint: Vitals of Parturient just after extraction of baby is considered as a baseline vital for this study. After extraction of baby oxytocin infusion will be started then after wards Coadministration of intravenous phenylephrine with 3U oxytocin over the 5 minutes then afterwards Intraoperative vital will be noted at every 5 minutes till the end of surgery.

Secondary

MeasureTime frame
To compare the effectiveness of two different doses of intravenous phenylephrine for preventing adverse changes in various hemodynamic parametersTimepoint: As per study, Hemodynamic Parameters will be noted at every 5 minutes till the end of surgery. At the extraction of baby and after administration of oxytocin infusion and intravenous phenylephrine with 3U oxytocin.;To evaluate the proportion of cases with any side effects in parturient following co-administration of oxytocin and phenylephrine.Timepoint: The extraction of baby from parturient to till the end of surgery by monitoring of any side effect at every 5 minutes during lower segment caesarean section.;To study the requirement of Total Rescue Dose of phenylephrine.Timepoint: Rescue doses of intravenous phenylephrine 50mcg will be given over 2minutes and will be repeated every 2 minutes till the mean arterial pressure increased upto within 20% of baseline (maximum 4 rescue doses of phenylephrine will be administered)

Countries

India

Contacts

Public ContactDr Subrat Agarwal

S.M.S Medical College Jaipur

drniharsharma@gmail.com9314044376

Outcome results

None listed

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