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

Dow University of Health Sciences

Status: Enrolling

Conditions: Spinal Anesthesia Induced Hypotension

Treatments: Drug: Norepinephrine Bolus; Drug: Phenylephrine bolus

Study type: Interventional

Funder types: Other

Identifiers

NCT06836986

spinal induced hypotension

Details and patient eligibility

About

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

Full 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.

Enrollment: 124 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 2 patient groups

Group P

Active Comparator group

Description:

Prophylactic bolus of phenylephrine will be administered right after spinal anesthesia induction

Treatment:

Drug: Phenylephrine bolus

Group N

Experimental group

Description:

Prophylactic bolus of norepinephrine will be administered right after spinal anesthesia.

Treatment:

Drug: Norepinephrine Bolus