Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Active Not Recruiting NCT07697651

Evaluation of Postoperative Hearing Loss After Spinal Anesthesia for Elective Cesarean Section in Pregnant Women

Conditions: Hearing Loss; Post-Dural Puncture Headache; Cesarean Delivery

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 53
Sponsor: Duzce University

Location: Duzce University Düzce

Summary

This prospective observational study will evaluate postoperative hearing changes in women undergoing elective cesarean delivery under spinal anesthesia. Pure-tone audiometry will be performed before spinal anesthesia and at the predefined postoperative assessment time. The incidence, onset time, and severity of post-dural puncture headache (PDPH) will also be assessed. The study aims to determine whether hearing threshold changes occur after spinal anesthesia and whether these changes are associated with PDPH.

Eligibility Criteria

Inclusion Criteria: * • Women aged 18 years or older. * Scheduled for elective cesarean delivery. * Planned spinal anesthesia. * ASA physical status I-II \[revise if another ASA range is approved in the protocol\]. * Ability to complete preoperative and postoperative pure-tone audiometry assessments. * Provision of written informed consent. Exclusion Criteria: * • Pre-existing hearing loss, use of hearing aids, or inability to complete audiometric testing. * History of chronic otologic disease, ear surgery, or active ear infection. * Contraindication to spinal anesthesia. * Conversion to general anesthesia before completion of the protocol assessments. * Refusal to participate or withdrawal of consent. * \[Add any protocol-specific exclusions approved by the ethics committee, such as chronic headache disorder, hypertensive disease of pregnancy, or major perioperative hemorrhage, only if applicable.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07697651). StuddyBuddy aggregates publicly available trial information.