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This prospective, double-blind, randomized controlled trial compares the effects of total intravenous anesthesia (TIVA) versus sevoflurane-based inhalational anesthesia on maternal hemodynamics, depth of anesthesia, and early neonatal clinical outcomes in pregnant women undergoing elective cesarean section under general anesthesia
Elective cesarean sections under general anesthesia present a unique clinical setting where maternal ventilation and depth of anesthesia directly influence uteroplacental circulation and neonatal adaptation. This single-center study included 80 pregnant women (ASA physical status II, 38 weeks of gestation or more) randomly allocated into two groups: the TIVA group (n=39) receiving propofol and remifentanil, and the Sevoflurane group (n=41) receiving sevoflurane and fentanyl. The study evaluates intraoperative maternal hemodynamics, Bispectral Index (BIS) monitoring for depth of anesthesia, postoperative pain using the Numeric Rating Scale (NRS), and neonatal outcomes including Apgar scores, the Neurologic and Adaptive Capacity Score (NACS), and umbilical cord blood gas analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total Intravenous Anesthesia (TIVA) | Active Comparator | Patients received propofol (2-2.5 mg/kg) and rocuronium for induction. Anesthesia was maintained with a propofol infusion (titrated according to hemodynamics and to maintain BIS between 40-55). Following delivery, remifentanil infusion was administered. |
|
| Sevoflurane Anesthesia | Active Comparator | Patients received propofol (2-2.5 mg/kg) and rocuronium for induction. Anesthesia was maintained with 2-3% sevoflurane in an oxygen-air mixture, titrated to maintain BIS between 40-55. Following delivery, an intravenous bolus of fentanyl was administered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | Administered intravenously for induction at a dose of 2 to 2.5 mg/kg. For maintenance in the TIVA group, a 2% propofol infusion was started at 14 mg/kg/hour at the 1st minute post-intubation, then decreased to 11 mg/kg/hour. The infusion rate was increased by increments of 2 mg/kg/hour if the Bispectral Index (BIS) exceeded 50 or if the heart rate increased by 10-20% from baseline. Following fascia closure, the rate was reduced to 6 mg/kg/hour and discontinued completely at skin closure. |
| Measure | Description | Time Frame |
|---|---|---|
| Depth of Anesthesia Assessed by Bispectral Index (BIS) | Anesthesia depth was monitored continuously using a four-channel frontal pEEG electrode to maintain a target BIS value between 40 and 55. The Bispectral Index scale ranges from a minimum of 0 to a maximum of 100. Lower scores indicate deeper sedation/anesthesia, while higher scores indicate a more awake state | During surgery (at 1, 2, 5, 10, 20, 30, 40 minutes and at the end of surgery) |
| Neonatal Neurologic and Adaptive Capacity Score (NACS) | The Neonatal Neurologic and Adaptive Capacity Score (NACS) is a neurobehavioral assessment scale for newborns. The scale ranges from a minimum score of 0 to a maximum score of 40. Higher scores indicate a better outcome (better neurological adaptation). Scores of 35 or above indicate normal/adequate neurological adaptation, while scores below 35 indicate inadequate adaptation | At 1 minute, 1 hour, and 24 hours post-delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Umbilical Cord Arterial pH | Analysis of umbilical cord blood evaluating pH, to assess the newborn's immediate postnatal transition and metabolic state. | within the first 5 minutes after delivery |
| Umbilical Cord Arterial pco2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Medipol University | Istanbul | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Sevoflurane | Drug | Following induction and intubation, anesthesia maintenance was carried out with 2-3% sevoflurane in a 50% oxygen-air mixture using low-flow inhalation anesthesia (1 L/min fresh gas flow). The concentration of the inhalational anesthetic agent was gradually titrated to maintain the target Bispectral Index (BIS) value between 40 and 55 throughout the surgery. |
|
Analysis of umbilical cord blood evaluating PCO2, to assess the newborn's immediate postnatal transition and metabolic state.
| Within the first 5 minutes after delivery |
| Umbilical Cord Arterial po2 | Analysis of umbilical cord blood evaluating PO2, to assess the newborn's immediate postnatal transition and metabolic state. | Within the first 5 minutes after delivery |
| Umbilical Cord total hemoglobin | Analysis of umbilical cord blood evaluating total hemoglobin, to assess the newborn's immediate postnatal transition and metabolic state. | Within the first 5 minutes after delivery |
| Umbilical Cord glucose levels | Analysis of umbilical cord blood evaluating glucose levels, to assess the newborn's immediate postnatal transition and metabolic state | Within the first 5 minutes after delivery |
| Maternal Systolic Blood Pressure (Unit: mmHg) | Continuous monitoring of systolic arterial blood pressures to assess maternal cardiovascular stability. | Intraoperative (Recorded from induction to the end of the operation) |
| Maternal diastolic Blood Pressure (Unit: mmHg) | Continuous monitoring of diastolic arterial blood pressures, to assess maternal cardiovascular stability. | Intraoperative (Recorded from induction to the end of the operation) |
| Maternal mean Blood Pressure (Unit: mmHg) | Continuous monitoring of mean arterial blood pressures, to assess maternal cardiovascular stability. | Intraoperative (Recorded from induction to the end of the operation) |
| Maternal Heart Rate | Continuous monitoring of heart rate to assess maternal cardiovascular stability. | Intraoperative (Recorded from induction to the end of the operation) |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |