Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07477093
Acronym
NEO-OXY-CS
Enrollment
49
Registered
2026-03-17
Start date
2020-01-02
Completion date
2023-01-02
Last updated
2026-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section, Neonatal Cerebral Oxygenation

Keywords

Neonatal cerebral oxygenation, Cesarean section, NIRS, General anesthesia, Spinal anesthesia, cFTOE, Near-infrared spectroscopy, Regional cerebral oxygen saturation, Neonate

Brief summary

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.

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.

Interventions

OTHERNo intervention (observational study)

No intervention - observational study only.

Sponsors

Akdeniz University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Neonatal Cerebral Regional Oxygen Saturation (crSO₂)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

MeasureTime frameDescription
Neonatal Peripheral Oxygen Saturation (SpO₂)From birth to 16 minutes after deliveryPeripheral oxygen saturation measured continuously using pulse oximetry on the right hand during the first 16 minutes after birth
Neonatal Heart Rate (HR)From birth to 16 minutes after deliveryHeart rate measured continuously using pulse oximetry during the first 16 minutes after birth.
Umbilical Cord Blood Gas ParametersAt deliveryUmbilical cord blood gas analysis showing pH measured immediately after delivery.
Cerebral Fractional Tissue Oxygen Extraction (cFTOE)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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026