Safety Evaluation of Dexmedetomidine Monitored Anesthesia Care for Endobronchial Ultrasound-guided Transbronchial Needle Aspiration
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Major adverse events
研究概览
简要总结
Lung cancer is the second most commonly diagnosed primary neoplasia in Canada accounting for 22 865 new cases in 2007. Recent randomized trials have shown a significantly better diagnostic yield and fewer unnecessary thoracotomies with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) when compared to conventional TBNA for various clinical conditions including peripheral pulmonary lesions and sarcoidosis. EBUS-TBNA are now routinely performed in our institution for staging of pulmonary and mediastinal cancer. EBUS-TBNA are performed under monitored anesthesia care (MAC) in the endoscopy suite at the Centre de soins ambulatoires of the Hôpital Maisonneuve-Rosemont.
Remifentanil, used in combined regime or as single agent proved to be effective and safe for MAC. Nonetheless, anesthesiologists are still confronted to the respiratory depression profile of remifentanil and other commonly used agents. An analysis of the ASA Closed Claims demonstrated that respiratory depression remains a significant drawback during MAC in remote locations. Furthermore, patients with coexisting pulmonary diseases scheduled for EBUS-TBNA are at increased risk of such complications.
The investigators hypothesize that compared to the use of remifentanil-based MAC protocol, the use of dexmedetomidine-based MAC protocol for EBUS-TBNA will result in a lower incidence of major respiratory and hemodynamic adverse events (bradypnea, apnea, oxygen desaturation, hypotension, hypertension, bradycardia and tachycardia) with equivalent overall procedure conditions.
详细描述
See above
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with planned EBUS-TBNA under conscious sedation.
- •Age 18-75 years old.
- •American Society of Anesthesiologists class I-III.
- •The subject is able to understand the study objectives, the experimental protocol and procedures, and is capable of providing an informed consent.
排除标准
- •Subjects allergic to any of the study drugs.
- •BMI > 34 kg/m
- •Severe renal or hepatic failure.
- •Pregnancy.
- •Emergent procedure.
- •Heart failure NYHA > III.
- •Systolic blood pressure < 90 mmHg.
- •Advanced heart block (unless patient has a pacemaker).
- •Unstable angina and/or myocardial infarction within past 6 weeks.
- •FEV1 ≤ 0.8 L.
- •Oxygen-dependent patient.
- •Use of α2-adrenoreceptor agonist or antagonist within 14 days.
研究组 & 干预措施
Remifentanil
干预措施: Remifentanil (Drug)
Dexmedetomidine
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Major adverse events
时间窗: Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis)
Bradypnea,apnea, oxygen desaturation, hypotension, hypertension, heart rate \<45 beats per minute, heart rate ≥120 beats per minute
次要结局
- Vocal cord movement(Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis))
- Sedation scores(Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis))
- Aldrete scores in the post anesthesia care unit(Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis))
- Nausea and vomiting(Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis))
- Cumulative dose of remifentanil or dexmedetomidine(Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis))
- Total dose of lidocaine(Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis))
- Total dose of vasopressor(Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis))
- Coughing episodes(Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis))
- Endoscopist satisfaction(Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis))
- Recall(Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis))
- Pain associated with the procedure (VAS)(Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis))
- Patient satisfaction(Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis))
研究者
Louis-Philippe Fortier
MD
Maisonneuve-Rosemont Hospital