Duzce University
Düzce, Turkey (Türkiye)
NCT Number: NCT07697651
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.
This study is active but is not currently recruiting participants.
18 year and older
Female
Observational
Düzce, Turkey (Türkiye)
Spinal anesthesia is routinely used for elective cesarean delivery. Dural puncture may be associated with cerebrospinal fluid pressure changes that can affect inner-ear fluid dynamics and may result in transient changes in hearing thresholds. Post-dural puncture headache is another clinically relevant complication that may reflect cerebrospinal fluid loss and pressure changes.
Eligible women scheduled for elective cesarean delivery under spinal anesthesia will be enrolled consecutively after providing written informed consent. Spinal anesthesia will be administered according to routine clinical practice, with no additional anesthetic intervention performed for research purposes. Demographic and perioperative variables, including spinal needle gauge, sensory block level, hemodynamic measurements, vasopressor use, and occurrence of post-dural puncture headache, will be recorded. Pure-tone audiometry will be performed before surgery and at the predefined postoperative assessment time. Postoperative hearing thresholds will be compared with baseline values, and their association with post-dural puncture headache will be evaluated.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: : Baseline preoperative assessment to postoperative audiometric assessment at 48 hours after spinal anesthesia
The primary outcome is the difference between preoperative and postoperative pure-tone audiometry thresholds at the tested frequencies in each ear. Hearing thresholds will be recorded in decibels hearing level (dB HL), and the change from baseline will be analyzed
Time frame: Within 7 days after spinal anesthesia.
Association between postoperative changes in hearing thresholds and the occurrence of post-dural puncture headache.
Duzce University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05532657
Aging, Brain Diseases
Hagerstown, Maryland, United States
View Trial DetailsNCT06545175
Ear Diseases, Hearing Disorders
Hanover, Germany
View Trial DetailsNCT06859788
Dizziness, Ear Diseases
Los Angeles, California, United States
View Trial DetailsNCT06370351
Congenital Deafness, DFNB9
Westmead, Australia
View Trial Details