Manually Controlled Continuous Infusion of Norepinephrine vs Phenylephrine During Spinal Anesthesia for Cesarean Section: A Double-blinded Randomized Controlled Study

What this Trial Is About

Researchers are evaluating the effects of norepinephrine versus phenylephrine infusions to maintain blood pressure during spinal anesthesia in women undergoing elective cesarean delivery. This randomized, double-blind controlled trial aims to compare neonatal outcomes measured by umbilical artery pH and maternal hemodynamics, hypothesizing that norepinephrine provides similar neonatal safety with more stable blood pressure and fewer heart rate drops. Participants receive either phenylephrine or norepinephrine as a continuous infusion started simultaneously with spinal anesthesia. The infusion rates are manually adjusted based on maternal systolic blood pressure measured every minute to keep values near baseline. Spinal anesthesia involves injecting hyperbaric bupivacaine with fentanyl, followed by rapid intravenous fluid expansion. The study drug concentrations and infusion protocols are standardized to ensure comparable dosing between groups. Throughout the cesarean procedure, maternal blood pressure and heart rate are closely monitored, with adjustments made to infusion rates as needed to manage hypotension, hypertension, and bradycardia. Umbilical arterial blood is sampled immediately after delivery to assess blood gases. Additional measures include recording newborn APGAR scores and any adverse maternal or neonatal events. The study's main outcome is umbilical artery pH, with various secondary outcomes tracked to evaluate safety and efficacy.

Continuous Infusion of Norepinephrine vs Phenylephrine During Spinal Anesthesia for Cesarean Section (INPEACE)