跳至主要内容
临床试验/NCT07386054
NCT07386054尚未招募不适用

The Effectiveness of Binaural Beats on Midazolam Requirement During Cesarean Section With Spinal Anesthesia

Yonsei University0 个研究点目标入组 100 人开始时间: 2026年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
the total dose of midazolam administered to achieve a score of ≤3 on the Observer's Assessment of Alertness/Sedation (OAA/S) scale during sedation induction.

研究概览

简要总结

Spinal anesthesia is preferred for cesarean section in many institutions due to concerns regarding the potential effects of general anesthetic agents on the fetus. However, during cesarean section under spinal anesthesia, parturients remain fully conscious and may experience significant anxiety, tension, or fear intraoperatively. For this reason, sedative agents such as midazolam are commonly administered after delivery, once the risk of neonatal exposure is considered minimal, to facilitate maternal sedation. Nevertheless, administration of midazolam at higher doses may be associated with adverse maternal effects, including respiratory depression, apnea, and hemodynamic instability.

Binaural beats are a brainwave entrainment technique in which two auditory stimuli of slightly different frequencies are presented separately to each ear, resulting in the perception of an interference frequency that may induce synchronization of brain activity. Previous studies have reported that exposure to binaural beats designed to generate low-frequency brainwaves associated with relaxation or sleep may reduce pain, anxiety, and promote sedation in both adult and pediatric populations.

The investigators hypothesize that the use of binaural beats during cesarean section under spinal anesthesia may reduce the required dose of midazolam for sedation, thereby decreasing the risk of drug-related adverse effects. The primary objective of this study is to evaluate whether exposure to binaural beats reduces the total dose of midazolam required for sedation in parturients undergoing cesarean section under spinal anesthesia. Secondary objectives include comparison of perioperative anxiety levels, maternal satisfaction, and other perioperative outcomes between the binaural beats group and the control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients aged ≥20 years undergoing cesarean section under spinal anesthesia who request intraoperative sedation.

排除标准

  • A. Parturients with hearing impairment or those using hearing aids B. Parturients who have received opioid analgesics or sedative medications within 1 week prior to enrollment C. Parturients with known hypersensitivity to benzodiazepines D. Parturients in whom a difficult airway is anticipated E. Parturients with arrhythmias, cardiovascular disease, impaired cardiac function, or reduced circulating blood volume F. Parturients with severe respiratory disease for whom the use of sedative medications is considered inappropriate G. Parturients with hepatic failure H. Parturients with renal failure or those receiving dialysis I. Parturients with other significant maternal medical histories or fetal conditions (e.g., fetal anomalies, intrauterine growth restriction) that are considered likely to increase maternal anxiety J. Patients who are unable to read the informed consent form (e.g., foreign nationals) K. Participants deemed inappropriate for participation in this clinical trial at the discretion of the investigator or study personnel

研究组 & 干预措施

ear phone with binaural beats

Experimental

Patient group who receives remimazolam for sedation after delivery

干预措施: binaural beats (Biological)

ear phone with no sound

Active Comparator

Patient group who receives midazolam for sedation after delivery

干预措施: Midazolam (Biological)

结局指标

主要结局

the total dose of midazolam administered to achieve a score of ≤3 on the Observer's Assessment of Alertness/Sedation (OAA/S) scale during sedation induction.

时间窗: 1, 2, 3, 4, 5, 10, 20, 30 minutes after sedative administration

The cumulative dose of midazolam administered from the initiation of sedation until achievement of an OAA/S score of ≤3 will be recorded.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

相似试验

The Effectiveness of Binaural Beats on Midazolam... | 临床试验