Clinical Trials Directory

Trials / Completed

CompletedNCT07477093

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
Phase
Study type
Observational
Enrollment
49 (actual)
Sponsor
Akdeniz University Hospital · Academic / Other
Sex
All
Age
18 Years – 40 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERNo intervention (observational study)No intervention - observational study only.

Timeline

Start date
2020-01-02
Primary completion
2023-01-02
Completion
2023-01-02
First posted
2026-03-17
Last updated
2026-03-17

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07477093. Inclusion in this directory is not an endorsement.