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Safety Evaluation of Dexmedetomidine for EBUS-TBNA
Conditions
Lung Cancer
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
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Intervention
Name: Remifentanil
Type: Drug
Name: Dexmedetomidine
Type: Drug
Overall Status
Recruiting
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.
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
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: 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.
- 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.
Location
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Status: Recruiting
Start Date
June 2011
Completion Date
June 2013
Sponsors
Maisonneuve-Rosemont Hospital
Source
Maisonneuve-Rosemont Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page