Effects of Spinal Versus General Anesthesia on Neonatal Cerebral Oxygenation During Cesarean Section (NEO-OXY-CS)

March 13, 2026 updated by: Bilge KARSLI, Akdeniz University Hospital

Evaluation of the Effects of Spinal and 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy pregnant women undergoing elective cesarean section and their neonates were included. Anesthesia type was determined by routine clinical practice. Neonatal cerebral oxygenation was monitored during early postnatal transition.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Spinal Anesthesia Group
Pregnant women undergoing elective cesarean section under spinal anesthesia (observational exposure)
Other: No intervention (observational study)
No intervention - observational study only.
General Anesthesia Group
Pregnant women undergoing elective cesarean section under general anesthesia (observational exposure).
Other: No intervention (observational study)
No intervention - observational study only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From birth to 16 minutes after delivery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Umbilical Cord Blood Gas Parameters
Time Frame: At delivery
Umbilical cord blood gas analysis showing pH measured immediately after delivery.
At delivery
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.
From birth to 16 minutes after delivery.
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.
From birth to 16 minutes after delivery
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
From birth to 16 minutes after delivery
Umbilical Cord Blood Gas Parameters
Time Frame: At delivery
Umbilical cord blood gas analysis including pO₂ measured immediately after delivery.
At delivery
Umbilical Cord Blood Gas Parameters
Time Frame: At delivery
Umbilical cord blood gas analysis including pCO₂ measured immediately after delivery
At delivery
Umbilical Cord Blood Gas Parameters
Time Frame: At delivery
Umbilical cord blood gas analysis including lactate measured immediately after delivery.
At delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2020

Primary Completion (Actual)

January 2, 2023

Study Completion (Actual)

January 2, 2023

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Akdeniz-ETHICS-193

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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