Effects of Binaural Beats on Inhaled Anesthetic Requirements During General Anesthesia in Pediatric Patients: A Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 68
- 主要终点
- The average EtSevo (end-tidal sevoflurane concentration, vol%) maintained during surgery.
研究概览
简要总结
The hypothesis of this study is that continuously delivering binaural beats with a phase difference corresponding to the slow-delta frequency band during anesthesia in pediatric patients can clinically and significantly reduce the required dose of the commonly used inhalational anesthetic, sevoflurane. To test this hypothesis, the study will compare the average end-tidal concentration of sevoflurane between a group exposed to continuous binaural beats (approximately 1 Hz phase difference) during surgery and a control group not exposed to such auditory stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients under 3 years of age undergoing superficial surgery lasting more than 1 hour under general anesthesia (e.g., nevus excision, polydactyly/syndactyly surgery, dermoid cyst excision, thyroglossal duct cyst excision, preauricular fistula excision, inguinal hernia repair, orchiopexy, other mass excisions, strabismus surgery, etc.).
- •American Society of Anesthesiologists (ASA) physical status classification I or II.
排除标准
- •Neonates or premature infants
- •Children with hearing impairment or currently using hearing aids
- •Children with neurological disorders
- •Children with respiratory diseases
- •Children undergoing neurosurgery or cardiac surgery
- •Other patients deemed inappropriate for inclusion in the clinical trial at the discretion of the investigator or study staff
研究组 & 干预措施
Binarual beat group
In this group, a binaural beat audio file is applied throughout the maintenance of anesthesia. The binaural beat consists of pure tones at 431 Hz in the left ear and 432 Hz in the right ear, delivered via earphones continuously until the end of anesthesia. Anesthesia is maintained with sevoflurane, and its concentration is adjusted to maintain a Patient State Index (PSI; SEDLine®; Masimo Corp., Irvine, USA) between 20 and 50. At the end of surgery, sevoflurane administration is discontinued, and ondansetron 0.1 mg/kg, acetaminophen 15 mg/kg, ketorolac 0.5 mg/kg, and a neuromuscular reversal agent are administered to facilitate emergence from anesthesia.
干预措施: Application of Binarual Beat (Other)
Control group
This group undergoes anesthesia using the conventional method, with maintenance of anesthesia achieved using sevoflurane. The concentration of sevoflurane is adjusted to maintain a Patient State Index (PSI; SEDLine®; Masimo Corp., Irvine, USA) between 20 and 50. At the end of surgery, sevoflurane administration is discontinued, and ondansetron 0.1 mg/kg, acetaminophen 15 mg/kg, ketorolac 0.5 mg/kg, and a neuromuscular reversal agent are administered to facilitate emergence from anesthesia.
结局指标
主要结局
The average EtSevo (end-tidal sevoflurane concentration, vol%) maintained during surgery.
时间窗: During surgery, more than 1 hour
次要结局
未报告次要终点
研究者
Ji-Hyun Lee
Associate Professor
Seoul National University Hospital