NCT01381627

Safety Evaluation of Dexmedetomidine for EBUS-TBNA

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Maisonneuve-Rosemont Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

See above

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Remifentanil	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.
DRUG	Dexmedetomidine	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.

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-06-27
• Last updated: 2013-02-28

Locations

1 site across 1 country: Canada