This is a single-center, prospective, single-blind randomized controlled trial. The investigators plan to recruit 144 pregnant women scheduled for cesarean delivery. Participants will be randomly assigned to receive either combined spinal-epidural anesthesia (CSEA) or general anesthesia (GA). The study aims to compare the effects of these two anesthetic techniques on neonatal hearing after cesarean delivery. The investigators will collect neonatal transient evoked otoacoustic emission (TEOAE) screening results and conduct follow-up hearing assessments at 3-6 months of age for infants who fail repeat screening. The investigators will also record maternal intraoperative hemodynamic changes, the interval from anesthesia initiation to neonatal delivery, neonatal Apgar scores at 1 and 5 minutes, and maternal postoperative pain scores at multiple time points.
None
Refusal to participate;
Contraindications to neuraxial anesthesia;
Severe comorbidities, including hypertensive disorders of pregnancy, cardiovascular disease, hepatic or renal dysfunction, or coagulation abnormalities;
History of psychiatric disorders, severe anxiety or depression, or chronic preoperative use of sedative or analgesic medications;
Parallel
Combined spinal-epidural anesthesia
Procedure/SurgeryCombined spinal-epidural anesthesia is administered for elective cesarean section according to the study protocol
General Anesthesia (GA)
Procedure/SurgeryGeneral anesthesia performed for cesarean delivery
1. Neonatal hearing screening pass rate by transient evoked otoacoustic emission (TEOAE)
The pass rate of neonatal transient evoked otoacoustic emission (TEOAE) hearing screening within 72 hours after birth.
Maternal intraoperative hemodynamic changes
Changes in maternal blood pressure and heart rate during cesarean section.
Neonatal Apgar scores
Apgar scores will be assessed at 1 and 5 minutes after birth. The Apgar score evaluates five components: Appearance, Pulse, Grimace, Activity, and Respiration. The total score ranges from 0 to 10, with higher scores indicating better neonatal condition and a better outcome.
Postoperative maternal VAS pain score
Postoperative maternal pain intensity will be assessed using the Visual Analog Scale (VAS) at 1, 6, 12, 24, and 48 hours after cesarean delivery. The VAS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
Click on the lead sponsor to view all of their trials.
