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

NCT06836986 | Recruiting

• 1 other identifier: spinal induced hypotension
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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

Conditions

Spinal Anesthesia Induced Hypotension

Keywords

Spinal anesthesia induced hypotension; Emergency lower segment cesarean section; Norepinephrine bolus; Prophylactic; Phenylephrine

Outcome Measures

Primary Outcomes (1)

• Incidence of spinal anesthesia induced Hypotension

  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.

  From induction of spinal anesthesia till delivery of neonate

Study Arms (2)

Group P

ACTIVE COMPARATOR

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

Drug: Phenylephrine bolus

Group N

EXPERIMENTAL

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

Drug: Norepinephrine Bolus

Interventions

Norepinephrine Bolus 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.

Group N

Phenylephrine bolus 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 P

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American society of anesthesiologists II and III patients
• Age 18-40years
• Gestational age 32 weeks and above

You may not qualify if:

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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

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

Karachi, Sindh, 74200, Pakistan

RECRUITING

Related Publications (2)

• 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.

  PMID: 38633922 BACKGROUND

• 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.

  PMID: 15106218 BACKGROUND

Central Study Contacts

Rabia Kamal, MBBS

CONTACT

923342239607; rabiakamal.ae@gmail.com

Arsalan Jamil, FCPS

CONTACT

923341226693; 22arsalan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: both participants and investigator is unaware about the drug given. Data is being collected by the anesthesiologist who is not involved in this study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FCPS Anesthesiology resident

Model Details: This study has two groups of participants. Group N and group P. Allocation of participants in each group is being done by basic randomization.

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 20, 2025
• Study Start: December 31, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

PA (1)