NCT07513870

Comparing Inhalational Anesthesia and TIVA on Maternal and Neonatal Hemodynamics in Elective Cesarean Section

Comparing The Effects Of Inhalational Anesthesia And Total Intravenous Anesthesia On Maternal And Neonatal Hemodynamic Dynamics In Elective Cesarean Section: A Prospective, Double-Blind, Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Medipol University · Academic / Other
• Sex: Female
• Age: 21 Years – 41 Years
• Healthy volunteers: Not accepted

Summary

This prospective, double-blind, randomized controlled trial compares the effects of total intravenous anesthesia (TIVA) versus sevoflurane-based inhalational anesthesia on maternal hemodynamics, depth of anesthesia, and early neonatal clinical outcomes in pregnant women undergoing elective cesarean section under general anesthesia

Detailed description

Elective cesarean sections under general anesthesia present a unique clinical setting where maternal ventilation and depth of anesthesia directly influence uteroplacental circulation and neonatal adaptation. This single-center study included 80 pregnant women (ASA physical status II, 38 weeks of gestation or more) randomly allocated into two groups: the TIVA group (n=39) receiving propofol and remifentanil, and the Sevoflurane group (n=41) receiving sevoflurane and fentanyl. The study evaluates intraoperative maternal hemodynamics, Bispectral Index (BIS) monitoring for depth of anesthesia, postoperative pain using the Numeric Rating Scale (NRS), and neonatal outcomes including Apgar scores, the Neurologic and Adaptive Capacity Score (NACS), and umbilical cord blood gas analysis.

Conditions

• Cesarean Section
• Anesthesia, General
• Anesthesia, Intravenous

Interventions

Type	Name	Description
DRUG	Propofol	Administered intravenously for induction at a dose of 2 to 2.5 mg/kg. For maintenance in the TIVA group, a 2% propofol infusion was started at 14 mg/kg/hour at the 1st minute post-intubation, then decreased to 11 mg/kg/hour. The infusion rate was increased by increments of 2 mg/kg/hour if the Bispectral Index (BIS) exceeded 50 or if the heart rate increased by 10-20% from baseline. Following fascia closure, the rate was reduced to 6 mg/kg/hour and discontinued completely at skin closure.
DRUG	Sevoflurane	Following induction and intubation, anesthesia maintenance was carried out with 2-3% sevoflurane in a 50% oxygen-air mixture using low-flow inhalation anesthesia (1 L/min fresh gas flow). The concentration of the inhalational anesthetic agent was gradually titrated to maintain the target Bispectral Index (BIS) value between 40 and 55 throughout the surgery.

Timeline

• Start date: 2024-03-15
• Primary completion: 2025-12-01
• Completion: 2026-01-05
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: Turkey (Türkiye)