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

NCT ID: NCT06836986

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2025-03-31

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.

Conditions

Spinal Anesthesia Induced Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group P

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

Group Type: ACTIVE_COMPARATOR

Phenylephrine bolus

Intervention Type: DRUG

Prophylactic phenylephrine bolus of 100 micrograms will be administered right after spinal anesthesia induction.

Rescue bolus of phenylephrine 50 micrograms will be administered in case of hypotension.

Group N

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

Group Type: EXPERIMENTAL

Norepinephrine Bolus

Intervention Type: DRUG

Prophylactic norepinephrine bolus of 8 micrograms will be administered right after spinal anesthesia induction.

Rescue bolus of norepinephrine 4 micrograms will be administered in case of hypotension.

Interventions

Norepinephrine Bolus

Prophylactic norepinephrine bolus of 8 micrograms will be administered right after spinal anesthesia induction.

Rescue bolus of norepinephrine 4 micrograms will be administered in case of hypotension.

Intervention Type: DRUG

Phenylephrine bolus

Prophylactic phenylephrine bolus of 100 micrograms will be administered right after spinal anesthesia induction.

Rescue bolus of phenylephrine 50 micrograms will be administered in case of hypotension.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dow University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Rabia Kamal

FCPS Anesthesiology resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dr Ruth km pfau civil hospital karachi Dow University of health sciences, department of anesthesiology

Karachi, Sindh, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Rabia Kamal, MBBS

Role: CONTACT

rabiakamal.ae@gmail.com

923342239607

Arsalan Jamil, FCPS

Role: CONTACT

22arsalan@gmail.com

923341226693

References

Nadella H, Islam A, Ina EA, Levin D, Bacoat-Jones T. The Management of Spinal and Epidural Anesthesia-Related Hypotension in the United States During Cesarean Childbirth. Cureus. 2024 Mar 17;16(3):e56340. doi: 10.7759/cureus.56340. eCollection 2024 Mar.

Reference Type: BACKGROUND

PMID: 38633922 (View on PubMed)

Ng K, Parsons J, Cyna AM, Middleton P. Spinal versus epidural anaesthesia for caesarean section. Cochrane Database Syst Rev. 2004;2004(2):CD003765. doi: 10.1002/14651858.CD003765.pub2.

Reference Type: BACKGROUND

PMID: 15106218 (View on PubMed)

Other Identifiers

spinal induced hypotension

Identifier Type: -

Identifier Source: org_study_id