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

Akdeniz University Hospital

Status: Completed

Conditions: Cesarean Section; Neonatal Cerebral Oxygenation

Treatments: Other: No intervention (observational study)

Study type: Observational

Funder types: Other

Identifiers

NCT07477093

Akdeniz-ETHICS-193

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

49 participants in 2 patient groups

Spinal Anesthesia Group

Description:

Pregnant women undergoing elective cesarean section under spinal anesthesia (observational exposure)

Treatment:

Other: No intervention (observational study)

General Anesthesia Group

Description:

Pregnant women undergoing elective cesarean section under general anesthesia (observational exposure).

Treatment:

Other: No intervention (observational study)