Safety Evaluation of Dexmedetomidine for EBUS-TBNA

Condition(s) targeted: Lung Cancer

Intervention: Remifentanil (Drug); Dexmedetomidine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Maisonneuve-Rosemont Hospital

Official(s) and/or principal investigator(s):
Olivier Verdonck, MD, Principal Investigator, Affiliation: Université de Montréal

Overall contact:
Olivier Verdonck, MD, Phone: 1-514-252-3426, Email: overdonck@gmail.com

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Primary outcome: Major adverse events

Secondary outcome:

Vocal cord movement

Sedation scores

Aldrete scores in the post anesthesia care unit

Nausea and vomiting

Cumulative dose of remifentanil or dexmedetomidine

Total dose of lidocaine

Total dose of vasopressor

Coughing episodes

Endoscopist satisfaction

Recall

Pain associated with the procedure (VAS)

Patient satisfaction

Detailed description: See above

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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.

Olivier Verdonck, MD, Phone: 1-514-252-3426, Email: overdonck@gmail.com

Hôpital Maisonneuve-Rosemont, Montreal, Quebec H1T 2M4, Canada; Recruiting

Starting date: June 2011
Last updated: February 27, 2013