Akdeniz University Hospital
Antalya, 07070, Turkey (Türkiye)
NCT Number: NCT07477093
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.
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Notify Me18 year–40 year
All sexes
Observational
Antalya, 07070, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No intervention - observational study only.
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.
Time frame: At delivery
Umbilical cord blood gas analysis showing pH measured immediately after delivery.
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.
Time frame: From birth to 16 minutes after delivery
Heart rate measured continuously using pulse oximetry during the first 16 minutes after birth.
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
Time frame: At delivery
Umbilical cord blood gas analysis including pO₂ measured immediately after delivery.
Time frame: At delivery
Umbilical cord blood gas analysis including pCO₂ measured immediately after delivery
Time frame: At delivery
Umbilical cord blood gas analysis including lactate measured immediately after delivery.
Akdeniz University Hospital
Other
Evaluation of the Effects of Spinal and General Anesthesia on Neonatal Cerebral Oxygenation During Cesarean Section
Acronym: NEO-OXY-CS
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