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

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

Study Overview

• Status: Completed
• Conditions: Anesthesia, General; Cesarean Section; Anesthesia, Intravenous
• Intervention / Treatment: Drug: Propofol; Drug: Sevoflurane

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Istanbul Medipol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pregnant women scheduled for elective cesarean section under general anesthesia.
• Gestational age of 38 weeks or greater.
• American Society of Anesthesiologists (ASA) physical status II.

Exclusion Criteria:

• Emergency cesarean section (Category 1 and 2).
• Presence of fetal distress. * ASA physical status III or higher.
• Preference for regional anesthesia.
• Antenatally detected fetal anomalies.
• Multiple pregnancies.
• Estimated birth weight less than 2400 grams.
• Known allergy to the study drugs or intraoperative adverse drug reactions.
• Severe eclampsia.
• Patients requiring conversion to general anesthesia due to inadequate spinal block.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Total Intravenous Anesthesia (TIVA); Patients received propofol (2-2.5 mg/kg) and rocuronium for induction. Anesthesia was maintained with a propofol infusion (titrated according to hemodynamics and to maintain BIS between 40-55). Following delivery, remifentanil infusion was administered.	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.
Active Comparator: Sevoflurane Anesthesia; Patients received propofol (2-2.5 mg/kg) and rocuronium for induction. Anesthesia was maintained with 2-3% sevoflurane in an oxygen-air mixture, titrated to maintain BIS between 40-55. Following delivery, an intravenous bolus of fentanyl was administered.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depth of Anesthesia Assessed by Bispectral Index (BIS)	Anesthesia depth was monitored continuously using a four-channel frontal pEEG electrode to maintain a target BIS value between 40 and 55. The Bispectral Index scale ranges from a minimum of 0 to a maximum of 100. Lower scores indicate deeper sedation/anesthesia, while higher scores indicate a more awake state	During surgery (at 1, 2, 5, 10, 20, 30, 40 minutes and at the end of surgery)
Neonatal Neurologic and Adaptive Capacity Score (NACS)	The Neonatal Neurologic and Adaptive Capacity Score (NACS) is a neurobehavioral assessment scale for newborns. The scale ranges from a minimum score of 0 to a maximum score of 40. Higher scores indicate a better outcome (better neurological adaptation). Scores of 35 or above indicate normal/adequate neurological adaptation, while scores below 35 indicate inadequate adaptation	At 1 minute, 1 hour, and 24 hours post-delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Umbilical Cord Arterial pH	Analysis of umbilical cord blood evaluating pH, to assess the newborn's immediate postnatal transition and metabolic state.	within the first 5 minutes after delivery
Umbilical Cord Arterial pco2	Analysis of umbilical cord blood evaluating PCO2, to assess the newborn's immediate postnatal transition and metabolic state.	Within the first 5 minutes after delivery
Umbilical Cord Arterial po2	Analysis of umbilical cord blood evaluating PO2, to assess the newborn's immediate postnatal transition and metabolic state.	Within the first 5 minutes after delivery
Umbilical Cord total hemoglobin	Analysis of umbilical cord blood evaluating total hemoglobin, to assess the newborn's immediate postnatal transition and metabolic state.	Within the first 5 minutes after delivery
Umbilical Cord glucose levels	Analysis of umbilical cord blood evaluating glucose levels, to assess the newborn's immediate postnatal transition and metabolic state	Within the first 5 minutes after delivery
Maternal Systolic Blood Pressure (Unit: mmHg)	Continuous monitoring of systolic arterial blood pressures to assess maternal cardiovascular stability.	Intraoperative (Recorded from induction to the end of the operation)
Maternal diastolic Blood Pressure (Unit: mmHg)	Continuous monitoring of diastolic arterial blood pressures, to assess maternal cardiovascular stability.	Intraoperative (Recorded from induction to the end of the operation)
Maternal mean Blood Pressure (Unit: mmHg)	Continuous monitoring of mean arterial blood pressures, to assess maternal cardiovascular stability.	Intraoperative (Recorded from induction to the end of the operation)
Maternal Heart Rate	Continuous monitoring of heart rate to assess maternal cardiovascular stability.	Intraoperative (Recorded from induction to the end of the operation)

Collaborators and Investigators

• Sponsor: Medipol University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2024
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): January 5, 2026

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Ethers; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Hydrocarbons, Halogenated; Hydrocarbons, Fluorinated; Methyl Ethers; Sevoflurane; Propofol
• Other Study ID Numbers: 302 14.03.2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No