COMPARISON OF FIXED DOSE BOLUS OF PHENYLEPHRINE 50 mcg IN TREATING POST SPINAL HYPOTENSION IN NORMOTENSIVE PARTURIENTS VERSUS PRE ECLAMPTIC PARTURIENTS UNDERGOING LOWER SEGMENT CESAREAN SECTION

A comparative study of efficacy of fixed dose bolus of 50 mcg for treatment of post spinal hypotension in pre-eclamptic and normotensive parturients undergoing lower segment cesarean section . - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/069489

Enrollment

Registered

2024-06-26

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

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: O140- Mild to moderate pre-eclampsia

Interventions

Intervention1: Intravenous Phenylephrine 50 mcg: Intravenous fixed bolus Phenylephrine 50 mcg administered to treat post spinal hypotension in pre eclamptic parturients undergoing lower segment cesare

Eligibility

Inclusion criteria

Inclusion criteria: Parturients between age 18-40 years with singleton pregnancy scheduled for caesarean section under spinal anaesthesia and who give written informed consent for study. American Society of Anaesthesiologists (ASA) Grade II BMI 18.5 - 30 kg/m2 and Height 150-160 cm. Parturients with pre-eclampsia. Parturients who develop hypotension post spinal

Exclusion criteria

Exclusion criteria: Patients not willing to give consent Patients with known allergy to study drug Parturients with partial HELLP or HELLP syndrome

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of Phenylephrine in treating hypotensionTimepoint: Baseline , 3 min, 6 min, 9 min, 12 min, 15 min, 18min, 21 min, 24min, 27 min, 30 min, 40 min, 50 min, 60 min	—

Secondary

Measure	Time frame
Umbilical artery blood pH APGAR Score at 1 min and 5 min Heart Rate, Mean Arterial Pressure, Systolic Blood Pressure, Diastolic Blood Pressure. Phenylephrine boluses required to treat first episode of post spinal hypotension. Total number of episodes of hypotension till the extraction of baby and entire intra op period. Timepoint: 3 min,6 min, 9 min, 12 min, 15 min, 18min, 21 min 24min 27 min 30 min 40 min 50 min 60 min	—

Measure

Time frame

Umbilical artery blood pH APGAR Score at 1 min and 5 min Heart Rate, Mean Arterial Pressure, Systolic Blood Pressure, Diastolic Blood Pressure. Phenylephrine boluses required to treat first episode of post spinal hypotension. Total number of episodes of hypotension till the extraction of baby and entire intra op period. Timepoint: 3 min,6 min, 9 min, 12 min, 15 min, 18min, 21 min 24min 27 min 30 min 40 min 50 min 60 min

—

Countries

India

Contacts

Public ContactDrRashmi DSouza

Bangalore edical College and Research Institute

rashmi.dsz10@gmail.com9901755424

Outcome results

None listed

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