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

RecruitingNAAges 18 Years - 35 YearsFemaleSecond Affiliated Hospital of Wenzhou Medical Uni…
NCT07852624 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Combined spinal-epidural anesthesia
  • General Anesthesia (GA)
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Where

1 site
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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