Comparison of Respiratory Tolerance to I.V. Versus Sublingual Sedation During Bronchoscopy.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Intensity of dyspnea
研究概览
简要总结
Bronchoscopy is a technique which currently allows the investigation of many respiratory diseases (infections, neoplasia, inflammation...) as well as endobronchial therapeutic procedures.
Good flexible bronchoscopy diagnostic practices suggest the use of anxiolytic premedication before endoscopy, but practices concerning the use of sedation further to the completion of the endoscopy are very heterogeneous.
We thus propose to compare, during a randomize, controlled trial, respiratory tolerance to I.V. versus sublingual sedation in two groups of patients indergoing bronchoscopy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged between 18 and 80, who will undergo bronchoscopy
- •FEV1≥ 50% of theorical value
- •Ambient air saturation at rest ≥ 94%
- •No allergy to midazolam, to hydroxyzine, Lidocaine (used for local anesthesia) or one of their compound
- •fasting for at least 6 hours
- •No indication against bronchoscopy, nor to premedication
- •Informed consent signed
排除标准
- •Pregnant or lactating, women
- •PAH patients
- •patients undergoing bronchoscopy with bronchoalveolar lavage and / or trans-bronchial biopsy
- •Patients with oral anticoagulants
研究组 & 干预措施
I.V. sedation
Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the I.V. sedation
干预措施: I.V Sedation (Drug)
sublingual sedation
Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the sublingual sedation group
干预措施: sublingual sedation (Drug)
结局指标
主要结局
Intensity of dyspnea
时间窗: 1 day
Intensity of dyspnea assessed by the patient 1h after bronchoscopy in both groups measured by VAS (visual analogue scale) score (in millimeters on a 0 to 100 scale).
次要结局
- OAAS Score(1 day)
- VAS Individual scores(1 day)
- Bronchoscopy duration(1 day)
- Blood pressure(1 day)
- Desaturation frequency(1 day)
- heart rate(1 day)
- Comparison of midazolam total dose(1 day)