Safety Evaluation of Dexmedetomidine for EBUS-TBNA

Study Overview
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Brief Summary
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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.

Detailed Description
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See above

Official Title
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Safety Evaluation of Dexmedetomidine Monitored Anesthesia Care for Endobronchial Ultrasound-guided Transbronchial Needle Aspiration

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: Remifentanil
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Subjects allergic to any of the study drugs. BMI > 34 kg/m2. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Remifentanil<br> | Drug: Remifentanil<br>* Remifentanil IV bolus 0.5 mcg/kg bolus in 10 minutes. Initial bolus followed by infusion 0.05-0.25 mcg/kg/min for OAA/S 2-3. Remifentanil IV bolus 0.3 mcg/kg PRN for time-limited painful stimuli.<br>* Other names: Ultiva;|
| Experimental: Dexmedetomidine<br> | Drug: Dexmedetomidine<br>* Dexmedetomidine 0.4 mcg/kg IV bolus in 10 minutes. Dexmedetomidine 0.5-1.0 mcgg/kg/h for OAA/S 2-3. Midazolam 0.015 mg/kg bolus IV PRN.<br>* Other names: Precedex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse events | Bradypnea,apnea, oxygen desaturation, hypotension, hypertension, heart rate <45 beats per minute, heart rate ≥120 beats per minute | Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vocal cord movement | Vocal cord movement before fiberscope passage | Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis) | 
| Sedation scores | Observer's Assessment of Alertness/Sedation Scale (OAA/S) throughout the EBUS-TBNA procedure. Specific time points: before fiberscope nasal insertion, before vocal cord passage, after vocal cord passage and at the end of the procedure. | 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 | Aldrete score immediately after removal of fiberscope, time for Aldrete score equal or superior to 9 (assesed at 5 minute intervals). | 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 | Cumulative dose of lidocaine administered by the endoscopist | 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 | Cumulative dose of vasopressor administered | Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis) | 
| Coughing episodes | Coughing episodes throughout the EBUS-TBNA procedure | Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis) | 
| Endoscopist satisfaction | Endoscopist global satisfaction score based on a 4-point Likert scale | Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis) | 
| Recall | Recall evaluation once Aldrete score superior to 9 in post anesthesia care unit. Evaluation based on a 4-point Likert scale | 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) | Maximal pain evaluation based on a visual analog scale. Score measured once an Aldrete score superior to 9 in the post anesthesia care unit is achieved. | Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis) | 
| Patient satisfaction | Global patient satisfaction associated with the procedure. Score based on a 5 point Likert scale. Measured before patient leaves 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultiva, EBUS-TBNA, Dexmedetomidine, Precedex, Remifentanil, Monitored Anesthesia Care, Sedation, Bronchoscopy, Lung cancer, Mediastinal node, Cancer staging, Anesthesia, Remote location