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Clinical Trials in China / NCT07852624
Recruiting Not applicable

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

NCT07852624 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Phase
Not applicable
Started
2025-08-02
Last updated
2026-10-08

Condition(s) studied

PregnancyNeonatal Hearing Function

Investigational drug(s) / intervention(s)

Combined spinal-epidural anesthesiaGeneral Anesthesia (GA)

Combined spinal-epidural anesthesia: Combined spinal-epidural anesthesia is administered for elective cesarean section according to the study protocol

General Anesthesia (GA): General anesthesia performed for cesarean delivery

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
35 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 1. Neonatal hearing screening pass rate by transient evoked otoacoustic emission (TEOAE) — Within 72 hours after delivery
    The pass rate of neonatal transient evoked otoacoustic emission (TEOAE) hearing screening within 72 hours after birth.

Trial sites (1)

FacilityCityRegionStatus
The Second Affiliated Hospital of Wenzhou Medical University Wenzhou China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07852624 on ClinicalTrials.gov ↗ ← All trials in China