To compare the incidence of hypotension and bradycardia by using two sympathomimetic drugs ,phenylephrine and noradrenaline among patients undergoing cesarean section under spinal anesthetia

Phase 4

Not yet recruiting

• Conditions: Other complications of spinal andepidural anesthesia during pregnancy,

• Registration Number: CTRI/2023/06/054376
• Lead Sponsor: Dr Y Surekha

Brief Summary

This is a type of randomised double blind interventional study where norepinephrine and Phenylephrine  infusions  will be given prophylactically in less dose and comparing those two drugs and observing which will prevent bradycardia in parturients undergoing cesarean section. Totally 2 groups, each group containing 64 persons. So total sample size will be 128 .

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-06-22
• Study Start: 2023-10-07

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 128

Inclusion Criteria

1)Parturients with uncomplicated term singleton pregnancy undergoing elective cesarean delivery and belonging to American Society of Anaesthesiologists classification 2 2) Age 18 to 35 yrs 3) Parturients giving informed written and valid consent.

Exclusion Criteria

• 1. parturients having hypertensive disorders of pregnancy, diabetes milletus, cardiac, cerebrovascular, renal disorders, oligohydramnios, IUGR.
• 2. parturients having hypersensitivity to any of the study drugs 3) parturients with known contraindications to spinal anaesthesia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the incidence of bradycardia among phenylephrine and norepinephrine groups	Measuring HR every 1 minute from onset of spinal action till delivery of baby

Secondary Outcome Measures

Name	Time	Method
Incidence of hypotensive episodes, maternal systolic and diastolic blood pressure, MAP,number of boluses of vasopressors required, reactive hypertension.	Measuring, BP and MAP every one minute from onset of spinal anaesthesia to delivery of the baby

Trial Locations

Locations (1)

Karnataka Institute of medical sciences; 🇮🇳 Dharwad, KARNATAKA, India

Karnataka Institute of medical sciences

🇮🇳Dharwad, KARNATAKA, India

Y surekha

Principal investigator

9032909554

rekhamedico96@gmail.com