NCT02157818已完成不适用
A Comparison of Dexmedetomidine Versus Midazolam for Conscious Sedation During Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- The number of Desaturation events
研究概览
简要总结
- Appropriate sedation is needed for medical diagnosis, treatment, and the safety for patients. In non-surgical approaches, benzodiazepines are broadly used for ideal sedated status for patients.
- However, especially in bronchoscope procedure, continuous monitoring of oxygen saturation is needed to prevent hypoxia due to respiratory distress induced by benzodiazepine.
- A alpha-2 agonist, dexmedetomidine, which has similar sedative effect, but has less adverse effect of respiratory distress compared to previous agents, was introduced.
- It is necessary to compare the efficacy and safety of dexmedetomidine with that of midazolam in ultrasound guided transbronchial needle aspiration (EBUS-TBNA).
- Double blind randomized trial
- Primary outcome: The number and duration of desaturation, volume of sedative, any use of rescue midazolam, and Ramsay Sedation Scale (RSS) score (for efficacy), and hypertension, tachycardia, any need for mandible support or manual ventilation, and any need for intubation (for safety).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who visit Seoul National University Hospital between 2014.04 - 2015.04
- •Patients who undergo EBUS-TBNA during the period
- •Aged between 18-75
- •Patients who meet the criteria of American Society of Anesthesiologists (ASA) physical status classification I-III
排除标准
- •American Society of Anesthesiologists (ASA) physical status classification >3
- •Have glomerular filtration rate (GFR) less than 15ml/min 1.73m2 or undergoing hemodialysis
- •End stage liver disease.
- •Impaired ventricular functions (EF <30%)
- •Patients with baseline oxygen desaturation (resting SpO2 <90%)
- •Asthma or chronic obstructive pulmonary disease or a forced expiratory volume in 1 s (FEV1)of < 1.0 liter
- •Bradycardia [baseline heart rate (HR)< 60 beats/min]
- •Hypotension [baseline systolic arterial pressure (SAP) < 100 mm Hg]
- •Pregnant state
- •Those intolerant or with an allergy to the study drug
- •those unable or who refused to give informed consent
研究组 & 干预措施
midazolam
Active Comparator
midazolam IV bolus 0.05ml/kg bolus in 1minute. rescue drug(Midazolam) 1 mg, IV boluses for double blinding setting, we use saline, 0.4 mcg/kg IV bolus in 10 minutes and 0.5 mcg/kg/h, as placebo.
干预措施: midazolam (Drug)
Dexmedetomidine
Experimental
Dexmedetomidine 0.4 mcg/kg IV bolus in 10 minutes. Dexmedetomidine 0.25-0.75 mcg/kg/h for RSS 3-5. Midazolam 1mg bolus IV pro re nata (PRN).
for double blinding setting, IV bolus 0.05ml/kg bolus in 1minute.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
The number of Desaturation events
时间窗: Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours
The number of desaturation (SpO2 \<90% for more than 5 seconds) events
次要结局
- Total dose of intratracheal lidocaine instillation(Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours)
- Duration of desaturation (sec)(Patient followed for the entire duration of EBUS-TBNA, an expected average of 2 hours)
- RSS score(Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours)
- Endoscopist satisfaction(Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room)
- Patient satisfaction(Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours)
- Use of rescue midazolam(Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours)
- Hemodynamic adverse event(Patient followed for the entire duration of EBUS-TBNA and until discharge of bronchoscopy room, an expected average of 2 hours)
研究者
Jinwoo Lee
Professor
Seoul National University Hospital
研究点 (1)
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