Effect of BIS Monitoring on Propofol Usage During Elective Bronchoscopy
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Total sedative dose in mg.
研究概览
简要总结
In this research, the investigators will asses the effect of BIS monitoring on propofol usage during elective flexible fiberoptic bronchoscopy.
The investigators will examine whether use of BIS monitor enables reduction of sedative dose during bronchoscopy.
The investigators will also examine whether administration of lower total sedative dose enables prevention of possible complications.
详细描述
During flexible fiberoptic bronchoscopy (FFP) a narrow optic tube is inserted via the mouth or nose into the airways. This allows direct visualization of the airways as well as taking different samples. In addition, this procedure allows opening of airway obstruction.
Administration of sedation during FFP is important, since this diminishes patient discomfort and body movements. It also lessens the untoward physiologic response to airway manipulation. In addition, patients requiring repeated examinations may refuse if they have suffered an unpleasant experience.
FFP is usually a brief procedure (several minutes up to an hour). Therefore, it is advantageous to use short acting drugs in order to shorten the prolonged post procedural monitoring and allow rapid patient discharge.
Several clinical trials have shown the superiority of propofol over midazolam for sedation during bronchoscopy regarding recovery of alertness, memory & motor function.
Propofol is a sedative-hypnotic with rapid onset and short duration. Using propofol, one can achieve rapid onset of sedation and faster recovery.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years old
- •Undergoing flexible fiberoptic bronchoscopy for lung tissue biopsy, airway lavage or opening of airway obstruction.
排除标准
- •Patient refusal/ inability to sign informed consent.
- •Age under 18 years of age.
- •Ventilated patients (via endotracheal tube or tracheostomy).
- •Known allergy for one of the anesthetic drugs.
- •Patients who suffered a stroke and/or have other neurological diseases.
- •Hemodynamically unstable patients (SBP below 90mmHg or above 180mmHg).
结局指标
主要结局
Total sedative dose in mg.
时间窗: Duration of flexible fiberoptic bronchoscopy (an average of 30 minutes)
次要结局
- Percentages of patients which developed complications resulting from use of sedatives(Duration of flexible fiberoptic bronchoscopy (an average of 30 minutes) up to 10 minutes after completion of procedure)
- Percentages of awareness during flexible fiberoptic bronchoscopy(Duration of flexible fiberoptic bronchoscopy (an average of 30 minutes))
研究者
Mordechai Kremer
Head of pulmonology institute
Rabin Medical Center