Trial Information
Safety Evaluation of Dexmedetomidine Monitored Anesthesia Care for Endobronchial Ultrasound-guided Transbronchial Needle Aspiration
See above
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Outcome Measure:
Major adverse events
Outcome Description:
Bradypnea,apnea, oxygen desaturation, hypotension, hypertension, heart rate <45 beats per minute, heart rate ≥120 beats per minute
Outcome Time Frame:
Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis)
Safety Issue:
Yes
Principal Investigator
Olivier Verdonck, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Université de Montréal
Authority:
Canada: Ethics Review Committee
Study ID:
11021
NCT ID:
NCT01381627
Start Date:
June 2011
Completion Date:
June 2013
Related Keywords:
- Lung Cancer
- EBUS-TBNA
- Dexmedetomidine
- Precedex
- Remifentanil
- Ultiva
- Monitored Anesthesia Care
- Sedation
- Bronchoscopy
- Lung cancer
- Mediastinal node
- Cancer staging
- Anesthesia
- Remote location
- Lung Neoplasms