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RECRUITING Not applicable ClinicalTrials.gov

Comparison of Different Anesthetic Techniques on Hearing Outcomes in Neonates After Cesarean Delivery

Sponsor: Second Affiliated Hospital of Wenzhou Medical University • ClinicalTrials.gov ID: NCT07852624

Registry updated: 2026-10-08
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Description

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.

Interventions

  • Combined spinal-epidural anesthesia (Procedure)
    Combined spinal-epidural anesthesia is administered for elective cesarean section according to the study protocol
  • General Anesthesia (GA) (Procedure)
    General anesthesia performed for cesarean delivery

Eligibility criteria

Inclusion Criteria:(a) Singleton pregnancy with gestational age 37-42 weeks; (b) Maternal age 18-35 years; (c) American Society of Anesthesiologists (ASA) physical status II; (d) Scheduled for elective cesarean delivery based on clinical indications; (e) Written informed consent obtained from the parturient and her family. Exclusion Criteria: 1. Refusal to participate; 2. Contraindications to neuraxial anesthesia; 3. Severe comorbidities, including hypertensive disorders of pregnancy, cardiovascular disease, hepatic or renal dysfunction, or coagulation abnormalities; 4. History of psychiatric disorders, severe anxiety or depression, or chronic preoperative use of sedative or analgesic medications; 5. Neonatal hyperbilirubinemia or birth weight \<2,500 g; 6. Anticipated intraoperative conditions that would prevent completion of the study per the prespecified protocol.

Conditions

Pregnancy Neonatal Hearing Function

Locations

  • The Second Affiliated Hospital of Wenzhou Medical University — Wenzhou, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record