Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
FEMALE
ID06836986

Comparison of Norepinephrine and Phenylephrine Boluses for Preventing Low Blood Pressure During Spinal Anesthesia in Women Undergoing Emergency Cesarean Section A Double-Blind Randomized Controlled Trial

Led by Dow University of Health Sciences · Updated on 2025-02-20

124

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether norepinephrine is more effective than phenylephrine in preventing low blood pressure caused by spinal anesthesia in women undergoing emergency cesarean sections. This study focuses on comparing these two drugs to see which one better reduces the incidence of spinal anesthesia induced hypotension, a common complication affecting both mother and baby during cesarean delivery. The research is conducted under a double-blind, randomized controlled trial design. Participants receive either a prophylactic bolus of norepinephrine or phenylephrine immediately after spinal anesthesia is given. In case of hypotension, rescue boluses of lower doses of the same drugs are administered. The study groups include Group N receiving norepinephrine and Group P receiving phenylephrine, with drug doses carefully monitored throughout the procedure. During the study, maternal heart rate, blood pressure, and other hemodynamic parameters are recorded every 3 minutes until the baby is delivered. Additionally, the newborn's APGAR scores are assessed to monitor immediate health. Data collection continues until delivery, and the primary outcome measured is the incidence of spinal anesthesia induced hypotension from anesthesia induction to delivery. The study is sponsored by Dow University of Health Sciences and runs until March 2025.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female participants aged 18 to 40 years
  • American Society of Anesthesiologists (ASA) physical status II or III
  • Gestational age of 32 weeks or more
Not Eligible

You will not qualify if you...

  • Hypertensive pregnancy disorders with systolic BP >160 mmHg or diastolic BP >99 mmHg
  • Baseline mean arterial pressure less than 70 mmHg
  • Antepartum hemorrhage or blood loss over 1000 ml during surgery
  • History of cardiovascular or neurological disease
  • Known fetal abnormalities
  • Current use of serotonin reuptake inhibitors, tricyclic antidepressants, or monoamine oxidase inhibitors
  • Maternal conditions requiring immediate general anesthesia

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - From spinal anesthesia induction until delivery of the neonate (typically a few hours)

Participants receive a prophylactic bolus of either norepinephrine or phenylephrine immediately after spinal anesthesia induction during emergency cesarean section. Rescue boluses are given if hypotension occurs. Hemodynamic parameters are monitored every 3 minutes until delivery of the neonate.

1 treatment session during cesarean delivery with continuous monitoring

Trial Site Locations

Total: 1 location

1

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

Karachi, Sindh, Pakistan, 74200

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Research Team

R

Rabia Kamal, MBBS

A

Arsalan Jamil, FCPS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

The Management of Spinal and Epidural Anesthesia-Related Hypotension in the United States During Cesarean Childbirth.

Harshita Nadella, Aditi Islam, Emily A Ina...

https://pubmed.ncbi.nlm.nih.gov/38633922