Anesthesia, General, Anesthesia, Intravenous, Cesarean Section
Conditions
Brief summary
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
Detailed description
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.
Interventions
DRUGPropofol
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.
DRUGSevoflurane
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.
Sponsors
Medipol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 41 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant women scheduled for elective cesarean section under general anesthesia. * Gestational age of 38 weeks or greater. * American Society of Anesthesiologists (ASA) physical status II.
Exclusion criteria
* Emergency cesarean section (Category 1 and 2). * Presence of fetal distress. \* ASA physical status III or higher. * Preference for regional anesthesia. * Antenatally detected fetal anomalies. * Multiple pregnancies. * Estimated birth weight less than 2400 grams. * Known allergy to the study drugs or intraoperative adverse drug reactions. * Severe eclampsia. * Patients requiring conversion to general anesthesia due to inadequate spinal block.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depth of Anesthesia Assessed by Bispectral Index (BIS) | During surgery (at 1, 2, 5, 10, 20, 30, 40 minutes and at the end of surgery) | 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 |
| Neonatal Neurologic and Adaptive Capacity Score (NACS) | At 1 minute, 1 hour, and 24 hours post-delivery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Umbilical Cord Arterial pH | within the first 5 minutes after delivery | Analysis of umbilical cord blood evaluating pH, to assess the newborn's immediate postnatal transition and metabolic state. |
| Umbilical Cord Arterial pco2 | Within the first 5 minutes after delivery | Analysis of umbilical cord blood evaluating PCO2, to assess the newborn's immediate postnatal transition and metabolic state. |
| Umbilical Cord Arterial po2 | Within the first 5 minutes after delivery | Analysis of umbilical cord blood evaluating PO2, to assess the newborn's immediate postnatal transition and metabolic state. |
| Umbilical Cord total hemoglobin | Within the first 5 minutes after delivery | Analysis of umbilical cord blood evaluating total hemoglobin, to assess the newborn's immediate postnatal transition and metabolic state. |
| Umbilical Cord glucose levels | Within the first 5 minutes after delivery | Analysis of umbilical cord blood evaluating glucose levels, to assess the newborn's immediate postnatal transition and metabolic state |
| Maternal Systolic Blood Pressure (Unit: mmHg) | Intraoperative (Recorded from induction to the end of the operation) | Continuous monitoring of systolic arterial blood pressures to assess maternal cardiovascular stability. |
| Maternal diastolic Blood Pressure (Unit: mmHg) | Intraoperative (Recorded from induction to the end of the operation) | Continuous monitoring of diastolic arterial blood pressures, to assess maternal cardiovascular stability. |
| Maternal mean Blood Pressure (Unit: mmHg) | Intraoperative (Recorded from induction to the end of the operation) | Continuous monitoring of mean arterial blood pressures, to assess maternal cardiovascular stability. |
| Maternal Heart Rate | Intraoperative (Recorded from induction to the end of the operation) | Continuous monitoring of heart rate to assess maternal cardiovascular stability. |
Countries
Turkey (Türkiye)
Outcome results
None listed