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NCT Number: NCT07513870

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

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

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Key information

Conditions

Cesarean Section Anesthesia, General Anesthesia, Intravenous

Age range

21 year–41 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propofol

Drug

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.

Sevoflurane

Drug

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.

Primary outcomes

  1. Depth of Anesthesia Assessed by Bispectral Index (BIS)

    Time frame: During surgery (at 1, 2, 5, 10, 20, 30, 40 minutes and at the end of surgery)

    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

  2. Neonatal Neurologic and Adaptive Capacity Score (NACS)

    Time frame: At 1 minute, 1 hour, and 24 hours post-delivery

    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

Secondary outcomes

  1. Umbilical Cord Arterial pH

    Time frame: within the first 5 minutes after delivery

    Analysis of umbilical cord blood evaluating pH, to assess the newborn's immediate postnatal transition and metabolic state.

  2. Umbilical Cord Arterial pco2

    Time frame: Within the first 5 minutes after delivery

    Analysis of umbilical cord blood evaluating PCO2, to assess the newborn's immediate postnatal transition and metabolic state.

  3. Umbilical Cord Arterial po2

    Time frame: Within the first 5 minutes after delivery

    Analysis of umbilical cord blood evaluating PO2, to assess the newborn's immediate postnatal transition and metabolic state.

  4. Umbilical Cord total hemoglobin

    Time frame: Within the first 5 minutes after delivery

    Analysis of umbilical cord blood evaluating total hemoglobin, to assess the newborn's immediate postnatal transition and metabolic state.

  5. Umbilical Cord glucose levels

    Time frame: Within the first 5 minutes after delivery

    Analysis of umbilical cord blood evaluating glucose levels, to assess the newborn's immediate postnatal transition and metabolic state

  6. Maternal Systolic Blood Pressure (Unit: mmHg)

    Time frame: Intraoperative (Recorded from induction to the end of the operation)

    Continuous monitoring of systolic arterial blood pressures to assess maternal cardiovascular stability.

  7. Maternal diastolic Blood Pressure (Unit: mmHg)

    Time frame: Intraoperative (Recorded from induction to the end of the operation)

    Continuous monitoring of diastolic arterial blood pressures, to assess maternal cardiovascular stability.

  8. Maternal mean Blood Pressure (Unit: mmHg)

    Time frame: Intraoperative (Recorded from induction to the end of the operation)

    Continuous monitoring of mean arterial blood pressures, to assess maternal cardiovascular stability.

  9. Maternal Heart Rate

    Time frame: Intraoperative (Recorded from induction to the end of the operation)

    Continuous monitoring of heart rate to assess maternal cardiovascular stability.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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