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.
See above
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
60
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.
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.
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
RECRUITINGMajor adverse events
Bradypnea,apnea, oxygen desaturation, hypotension, hypertension, heart rate \<45 beats per minute, heart rate ≥120 beats per minute
Time frame: Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis)
Vocal cord movement
Vocal cord movement before fiberscope passage
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis)
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