COMPARISON BETWEEN EFFICACY OF NOREPINEPHRINE AND PHENYLEPHRINE BOLUSES for PREVENTION OF SPINAL ANAESTHESIA INDUCED HYPOTENSION IN OBSTETRICAL PATIENTS UNDERGOING EMERGENCY CESAREAN SECTION-A Double Blind Randomized Controlled Trial

Not Applicable

Recruiting

• Conditions: Spinal Anesthesia Induced Hypotension
• Interventions: Drug: Phenylephrine bolus; Drug: Norepinephrine Bolus

• Registration Number: NCT06836986
• Lead Sponsor: Dow University of Health Sciences

Brief Summary

The goal of this clinical trial is to learn if norepinephrine is more effective than phenylephrine for prevention of spinal anesthesia induced hypotension. The main questions it aims to answer are:

Does norepinephrine lower the incidence of spinal anesthesia induced hypotension in emergency obstetrical patients? We will compare effectiveness of norepinephrine and phenylephrine for the prevention of spinal anesthesia induced hypotension.

Participants will:

Be administered prophylactic boluses of both drugs right after spinal anesthesia induction and maternal hemodynamic parameters and neonatal APGAR scores will be recorded

Detailed Description

Spinal anesthesia is a common mode of anesthesia in cesarean delivery. Spinal anesthesia induced hypotension is one of the most common complication that can affect both mother and fetus. For the management of spinal anesthesia induced hypotension, preloading with crystalloids and colloids, use on ionotropic agents and vasopressors have already been in practice.

Objective of this study is to compare efficacy of prophylactic use of norepinephrine and phenylephrine bolus dosage for spinal anesthesia induced hypotension.

This study is being conducted at the department of anesthesiology ,K.M Pfau civil hospital, Dow university of health sciences, Karachi , Pakistan. Data is being collected after taking approval from Institutional review board and written informed consent from the participants.

Participants are being enrolled by primary investigator. All participants are undergoing simple randomization by lottery method.

After enrollment of participants, demographic data, hemodynamic parameters and other relevant details are being recorded till delivery of the neonate.

Hemodynamic parameters that are heart rate, systolic and diastolic blood pressure, mean arterial blood pressure is being recorded every 3mins. APGAR scoring of neonate is also being recorded.

After completion of data collection, data will be done using Statistical package for social sciences 26.

Study Timeline

• Study Start: 2024-12-31
• Status Verified: 2025-02
• Study First Submitted: 2025-02-16
• Study First Submitted QC: 2025-02-16
• Last Update Submitted: 2025-02-16
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 124

Inclusion Criteria

1. American society of anesthesiologists II and III patients
2. Age 18-40years
3. Gestational age 32 weeks and above

Exclusion Criteria

1. Patients with hypertensive disorders of pregnancy having baseline systolic blood pressure greater than 160 mmHg and diastolic blood pressure greater than 99 mmHg.
2. Baseline mean arterial pressure less than 70 mmHg.
3. Antepartum hemorrhage/intraoperative blood loss greater than 1000ml
4. history indicative of cardiovascular or neurological disease.
5. known fetal abnormality.
6. Patients taking serotonin reuptake inhibitor, Tricyclic antidepressants,monoamine oxidase inhibitors.
7. Maternal situations requiring immediate administration of general anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group P	Phenylephrine bolus	Prophylactic bolus of phenylephrine will be administered right after spinal anesthesia induction
Group N	Norepinephrine Bolus	Prophylactic bolus of norepinephrine will be administered right after spinal anesthesia.

Primary Outcome Measures

Name	Time	Method
Incidence of spinal anesthesia induced Hypotension	From induction of spinal anesthesia till delivery of neonate	Prophylactic norepinephrine and phenylephrine boluses will be administered to both groups right after spinal anesthesia induction.greater than 80% drop of the Systolic blood pressure will be defined as hypotension.

Trial Locations

Locations (1)

Dr Ruth km pfau civil hospital karachi Dow University of health sciences, department of anesthesiology; 🇵🇰 Karachi, Sindh, Pakistan