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/38633922Actively Recruiting
Led by Dow University of Health Sciences · Updated on 2025-02-20
124
Participants Needed
1
Research Sites
N/A
Total Duration
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
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
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Total: 1 location
1
Dr Ruth km pfau civil hospital karachi Dow University of health sciences, department of anesthesiology
Karachi, Sindh, Pakistan, 74200
Actively Recruiting
R
Rabia Kamal, MBBS
A
Arsalan Jamil, FCPS
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Harshita Nadella, Aditi Islam, Emily A Ina...
https://pubmed.ncbi.nlm.nih.gov/38633922K Ng, J Parsons, A M Cyna...
https://pubmed.ncbi.nlm.nih.gov/15106218