Safety Evaluation of Dexmedetomidine for EBUS-TBNA

Trial Title: Safety Evaluation of Dexmedetomidine for EBUS-TBNA

NCT ID: NCT01381627

Condition: Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Dexmedetomidine
Remifentanil

Conditions: Keywords:
EBUS-TBNA
Dexmedetomidine
Precedex
Remifentanil
Ultiva
Monitored Anesthesia Care
Sedation
Bronchoscopy
Lung cancer
Mediastinal node
Cancer staging
Anesthesia
Remote location

Study type: Interventional

Study phase: Phase 4

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Single (Participant)

Intervention:

Intervention type: Drug
Intervention name: Remifentanil
Description: 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.
Arm group label: Remifentanil

Other name: Ultiva

Intervention type: Drug
Intervention name: Dexmedetomidine
Description: 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.
Arm group label: Dexmedetomidine

Other name: Precedex

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

Criteria for eligibility:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Hôpital Maisonneuve-Rosemont

Address:
City: Montreal
Zip: H1T 2M4
Country: Canada

Status: Recruiting

Start date: June 2011

Completion date: June 2013

Lead sponsor:
Agency: Maisonneuve-Rosemont Hospital
Agency class: Other

Source: Maisonneuve-Rosemont Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01381627