Effects of Music and Maternal Voice on Sedation Depth and Sedative Use During Pediatric
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- amount of propofol dose used in sedation
研究概览
简要总结
To evaluate the effects of music and maternal voice in children on sedation depth and sedative use during pediatric magnetic resonance imaging.
详细描述
When the patients and their parents arrived in the magnetic resonance unıt about 30 minutes before the procedure, the anesthetist is obtained a medical history and carried out a physical examination and clinical assesment.
Patients were categorized into 3 groups: music, maternal voice and isolation. During the procedures,the patients in the music group listened to Vivaldi's The Four Seasons violin concertos by sound isolating headphones, whereas the patients in the isolation group wore the headphones but did not listen to music.
All patients were sedated by midazolam and propofol. During the procedure, an additional propofol was administered as required
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA (American Society of Anesthesiologists) I-II
排除标准
- •Patients with hearing impairment, distorted ear anatomy, recent organ or system deficiency, severe pulmonary and/or cardiovascular problems, intolerance to propofol, airway ab-normalities, or known psychiatric or mental problems were ex-cluded from the study.
结局指标
主要结局
amount of propofol dose used in sedation
时间窗: during the MRI procedure
The total propofol dosage were recorded in during procedure.
次要结局
未报告次要终点
研究者
Özlem ÖZ GERGİN
Principal Investigator
TC Erciyes University