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

Study acronym: ATHNCD
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Secondary endpoints: details revised at 2 of 3 entries
    • Study description expanded, about 22 words
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07852624
Lead Sponsor Second Affiliated Hospital of Wenzhou Medical University
Conditions
(from sponsor)		 Pregnancy, Neonatal Hearing Function
Enrollment 144 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov