NCT04211298Unknown4 期
Dexmedetomidine Versus Propofol Sedation in Flexible Bronchoscopy: A Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- number of de-saturation events
研究概览
简要总结
The study will evaluate clinical outcomes during bronchoscopy procedures with dexmedetomidine in comparison to propofol.
The clinical outcomes that will be evaluated are: oxygen saturation, transcutaneous Pco2, blood pressure and complications
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients in the age group 18 to 70 years requiring flexible bronchoscopic evaluation of the airway in the Pulmonary institute at Rabin medical center
排除标准
- •known or suspected allergy to any of the study drugs, seizure disorder, renal (with serum creatinine > 2 mg/dL) or hepatic impairment (elevated liver enzymes > 2 times normal), haemodynamic instability (bradycardia with HR < 50 bpm or hypotension with SBP < 90 mmHg), or seriously ill patients with American Society of Anesthesiologists' physical status above III
研究组 & 干预措施
Propofol
Placebo Comparator
Propofol will be used for sedation during bronchoscopy
干预措施: Propofol (Drug)
Dexmedetomidine
Active Comparator
Dexmedetomidine will be used for sedation during bronchoscopy
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
number of de-saturation events
时间窗: During the procedure
Number of events during bronchoscopy when saturation level decreased under 90%
Oxygen saturation time < 90%
时间窗: During the procedure
Total time during the procedure that the oxygen saturation was under 90%
次要结局
未报告次要终点
研究者
Mordechai Kremer
Head of the pulmonary division
Rabin Medical Center
研究点 (1)
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