Skip to main content
OpenTrials
Completed

NCT Number: NCT07477093

Effects of Spinal Versus General Anesthesia on Neonatal Cerebral Oxygenation During Cesarean Section

This prospective observational study evaluates and compares the effects of spinal and general anesthesia techniques used during elective cesarean section on neonatal cerebral regional oxygen saturation (crSO₂) during the early transition to extrauterine life. Near-infrared spectroscopy (NIRS) was used to continuously monitor neonatal cerebral oxygenation for the first 16 minutes after birth. Neonatal heart rate, peripheral oxygen saturation (SpO₂), cerebral fractional tissue oxygen extraction (cFTOE), umbilical cord blood gas parameters, birth weight, and APGAR scores were also recorded.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Akdeniz University Hospital

Antalya, 07070, Turkey (Türkiye)

About this study

The transition from intrauterine to extrauterine life represents a critical period for neonatal cerebral oxygenation. Both spinal and general anesthesia may influence maternal hemodynamics and placental perfusion, potentially affecting neonatal oxygen delivery. This prospective observational clinical study was conducted between January 2020 and January 2023 after approval by the Akdeniz University Faculty of Medicine Clinical Research Ethics Committee. Forty-nine pregnant women aged 18-40 years with ASA physical status II and gestational age between 36 and 41 weeks who underwent elective cesarean delivery were enrolled. Participants were allocated into two groups based on anesthesia technique: spinal anesthesia (n=29) and general anesthesia (n=20).

Neonates were monitored immediately after birth using near-infrared spectroscopy with a sensor placed on the right frontal region. Cerebral regional oxygen saturation (crSO₂) was recorded at 2-minute intervals for 16 minutes. Simultaneously, neonatal heart rate and peripheral oxygen saturation were measured. Cerebral fractional tissue oxygen extraction (cFTOE) was calculated. Umbilical cord blood gas analysis, neonatal birth weight, and 1st- and 5th-minute APGAR scores were recorded. Primary analyses compared neonatal cerebral oxygenation parameters between anesthesia groups. Secondary analyses evaluated the effect of maternal hypotension requiring vasopressor treatment on neonatal cerebral oxygenation.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pregnant women aged 18-40 years
  • ASA physical status II
  • Gestational age between 36 and 41 weeks
  • Undergoing elective cesarean section
  • Singleton pregnancy
  • Provided written and verbal informed consent

Exclusion criteria

  • Emergency cesarean delivery
  • ASA physical status ≥ III
  • Smoking or alcohol use
  • Presence of chronic systemic disease
  • Preeclampsia, eclampsia, or other pregnancy-related complications
  • Preterm (<36 weeks) or post-term (>41 weeks) pregnancy
  • Multiple gestation
  • Placental implantation or adhesion anomalies
  • Neonates requiring resuscitation or supplemental oxygen after birth
  • Maternal intraoperative desaturation requiring oxygen supplementation

Treatment and study plan

No intervention (observational study)

Other

No intervention - observational study only.

Primary outcomes

  1. Neonatal Cerebral Regional Oxygen Saturation (crSO₂)

    Time frame: From birth to 16 minutes after delivery.

    Cerebral regional oxygen saturation measured non-invasively using near-infrared spectroscopy (NIRS) with a sensor placed on the right frontal region. Measurements were recorded at 2-minute intervals during the first 16 minutes after birth.

Secondary outcomes

  1. Umbilical Cord Blood Gas Parameters

    Time frame: At delivery

    Umbilical cord blood gas analysis showing pH measured immediately after delivery.

  2. Cerebral Fractional Tissue Oxygen Extraction (cFTOE)

    Time frame: From birth to 16 minutes after delivery.

    Calculated from cerebral regional oxygen saturation and peripheral oxygen saturation values during the first 16 minutes after birth.

  3. Neonatal Heart Rate (HR)

    Time frame: From birth to 16 minutes after delivery

    Heart rate measured continuously using pulse oximetry during the first 16 minutes after birth.

  4. Neonatal Peripheral Oxygen Saturation (SpO₂)

    Time frame: From birth to 16 minutes after delivery

    Peripheral oxygen saturation measured continuously using pulse oximetry on the right hand during the first 16 minutes after birth

  5. Umbilical Cord Blood Gas Parameters

    Time frame: At delivery

    Umbilical cord blood gas analysis including pO₂ measured immediately after delivery.

  6. Umbilical Cord Blood Gas Parameters

    Time frame: At delivery

    Umbilical cord blood gas analysis including pCO₂ measured immediately after delivery

  7. Umbilical Cord Blood Gas Parameters

    Time frame: At delivery

    Umbilical cord blood gas analysis including lactate measured immediately after delivery.

Sponsors and collaborators

Lead sponsor

Akdeniz University Hospital

Other

Registry information

Official study title

Evaluation of the Effects of Spinal and General Anesthesia on Neonatal Cerebral Oxygenation During Cesarean Section

Acronym: NEO-OXY-CS

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 17, 2026
Registry last updated
Mar 17, 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.

Published trials that share one or more normalized conditions with this study.