Evaluation of Postoperative Hearing Loss After Spinal Anesthesia for Elective Cesarean Section in Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Change in Pure-Tone Audiometry Hearing Thresholds After Spinal Anesthesia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• 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.
排除标准
- •• 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.
结局指标
主要结局
Change in Pure-Tone Audiometry Hearing Thresholds After Spinal Anesthesia
时间窗: : 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
次要结局
未报告次要终点