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

NCT07513870 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-07

No results posted yet for this study

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

Conditions

  • Cesarean Section
  • Anesthesia, General
  • Anesthesia, Intravenous

Interventions

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.

Sponsors & Collaborators

  • Medipol University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
41 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-15
Primary Completion
2025-12-01
Completion
2026-01-05

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07513870 on ClinicalTrials.gov