The Effect of Sedation During Transesophageal Echocardiography on Heart Rate Variability:A Comparison of Hypnotic Sedation With Medical Sedation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Hypnotic sedation
研究概览
简要总结
There is no ideal sedation technique that can be used during Transesophageal Echocardiography (TEE), and the data concerning the effects of available sedation techniques on Heart Rate Variability (HRV) are limited. In this study the investigators aimed at comparing the effects of sedation through hypnotherapy with medical sedation achieved by midazolam on HRV.
详细描述
Seventy-six patients with an indication of TEE will be recruited, the age range will be 18-83 years. In Group Topical (T) there are 26 patients who had the procedure under topical pharyngeal anesthesia, in Group Midazolam (D) there are 25 patients who will receive midazolam and in Group H there are 27 patients receiving hypnosis. All patients will have an IV access; throughout the procedure heart rate, rhythm ECG, peripheric O2 saturation will be monitored with a non-invasive monitor, blood pressure measurements were taken every 3 minutes. Rhythm Holter recordings will be obtained from all patients and TEE will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 83 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a need of transesophageal echocardiography
排除标准
- •Heart failure
- •Bad overall condition
- •Arrhythmia
研究组 & 干预措施
topical pharyngeal anesthesia
There were 26 patients who had the procedure under topical pharyngeal anesthesia.
干预措施: local anesthesia (Drug)
topical pharyngeal anesthesia
There were 26 patients who had the procedure under topical pharyngeal anesthesia.
干预措施: hypnosis (Behavioral)
midazolam
There were 25 patients who received midazolam.
干预措施: hypnosis (Behavioral)
midazolam
There were 25 patients who received midazolam.
干预措施: Midazolam (Drug)
结局指标
主要结局
Hypnotic sedation
时间窗: two months
Contrary to sedation with midazolam; when hypnosis is used for sedation in TEE patients, autonomic cardiac tone is modified to a significant extent. Hypnotic sedation achieves this by increasing the parasympathetic activity, decreasing the sympathetic activity and changing the sympathovagal interaction balance.
次要结局
未报告次要终点
研究者
Murat Gonenc
Cardiology Clinic
Bakirkoy Dr. Sadi Konuk Research and Training Hospital