NCT07311642尚未招募不适用
The Effect of Intraoperative Binaural Beats on Remimazolam Dose Required for Maintenance of General Anesthesia: a Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 88
- 主要终点
- Total intraoperative remimazolam dose
研究概览
简要总结
This prospective randomized controlled trial evaluates whether intraoperative binaural beats reduce the remimazolam dose required for general anesthesia in 88 adults undergoing breast surgery. Patients are assigned to binaural beats or silent earphones, and the primary outcome is total intraoperative remimazolam consumption.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥19 years old) scheduled to undergo breast surgery with reconstruction under general anesthesia.
排除标准
- •Patients with hearing impairment, hearing loss, or those using hearing aids
- •Patients with external auditory canal disease that prevents wearing earphones
- •Patients with chronic use of hypnotics or sedatives
- •Patients with a history of obstructive sleep apnea or a BMI ≥ 35 kg/m²
- •Patients with alcohol dependence or substance abuse
- •Patients deemed inappropriate for study participation at the discretion of the investigator
结局指标
主要结局
Total intraoperative remimazolam dose
时间窗: From induction of anesthesia to end of surgery
Total amount of remimazolam administered during general anesthesia
次要结局
- Heart rate(intraoperative)
- Total intraoperative remifentanil dose(Intraoperative period)
- BIS(Intraoperative period)
- SpO₂(intraoperative)
- Postoperative antiemetic use(PACU until Postoperative day 1)
- Postoperative analgesic use(PACU until Postoperative day 1)
- blood pressure(intraoperative)
研究者
Jeong-Hwa Seo
Professor
Seoul National University Hospital
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