Safety Evaluation of Dexmedetomidine for EBUS-TBNA - Full Text View

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: Remifentanil Drug: Dexmedetomidine	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care
Official Title:	Safety Evaluation of Dexmedetomidine Monitored Anesthesia Care for Endobronchial Ultrasound-guided Transbronchial Needle Aspiration

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Nausea and Vomiting

Drug Information available for: Dexmedetomidine Remifentanil hydrochloride Dexmedetomidine hydrochloride

U.S. FDA Resources

Further study details as provided by Maisonneuve-Rosemont Hospital:

Primary Outcome Measures:

Major adverse events [ Time Frame: Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis) ] [ Designated as safety issue: Yes ]
Bradypnea,apnea, oxygen desaturation, hypotension, hypertension, heart rate <45 beats per minute, heart rate ≥120 beats per minute

Secondary Outcome Measures:

Vocal cord movement [ Time Frame: Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis) ] [ Designated as safety issue: No ]
Vocal cord movement before fiberscope passage
Sedation scores [ Time Frame: Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis) ] [ Designated as safety issue: No ]
Observer's Assessment of Alertness/Sedation Scale (OAA/S) throughout the EBUS-TBNA procedure. Specific time points: before fiberscope nasal insertion, before vocal cord passage, after vocal cord passage and at the end of the procedure.
Aldrete scores in the post anesthesia care unit [ Time Frame: Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis) ] [ Designated as safety issue: No ]
Aldrete score immediately after removal of fiberscope, time for Aldrete score equal or superior to 9 (assesed at 5 minute intervals).
Nausea and vomiting [ Time Frame: Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis) ] [ Designated as safety issue: No ]
Cumulative dose of remifentanil or dexmedetomidine [ Time Frame: Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis) ] [ Designated as safety issue: No ]
Total dose of lidocaine [ Time Frame: Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis) ] [ Designated as safety issue: No ]
Cumulative dose of lidocaine administered by the endoscopist
Total dose of vasopressor [ Time Frame: Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis) ] [ Designated as safety issue: No ]
Cumulative dose of vasopressor administered
Coughing episodes [ Time Frame: Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis) ] [ Designated as safety issue: No ]
Coughing episodes throughout the EBUS-TBNA procedure
Endoscopist satisfaction [ Time Frame: Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis) ] [ Designated as safety issue: No ]
Endoscopist global satisfaction score based on a 4-point Likert scale
Recall [ Time Frame: Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis) ] [ Designated as safety issue: No ]
Recall evaluation once Aldrete score superior to 9 in post anesthesia care unit. Evaluation based on a 4-point Likert scale
Pain associated with the procedure (VAS) [ Time Frame: Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis) ] [ Designated as safety issue: No ]
Maximal pain evaluation based on a visual analog scale. Score measured once an Aldrete score superior to 9 in the post anesthesia care unit is achieved.
Patient satisfaction [ Time Frame: Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis) ] [ Designated as safety issue: No ]
Global patient satisfaction associated with the procedure. Score based on a 5 point Likert scale. Measured before patient leaves the post anesthesia care unit.

Estimated Enrollment:	60
Study Start Date:	June 2011
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Remifentanil	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. Other Name: Ultiva
Experimental: Dexmedetomidine	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. Other Name: Precedex

Detailed Description:

See above

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01381627

Contacts

Contact: Olivier Verdonck, MD	1-514-252-3426	overdonck@gmail.com
Contact: Nadia Godin, RN	1-514-252-3400 ext 3193	ngodin.hmr@ssss.gouv.qc.ca

Locations

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

Sponsors and Collaborators

Maisonneuve-Rosemont Hospital

Investigators

Principal Investigator:

Olivier Verdonck, MD

Université de Montréal

More Information

No publications provided

Responsible Party:	Louis-Philippe Fortier, MD, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier:	NCT01381627 History of Changes
Other Study ID Numbers:	11021
Study First Received:	June 21, 2011
Last Updated:	February 27, 2013
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Maisonneuve-Rosemont Hospital:

EBUS-TBNA
Dexmedetomidine
Precedex
Remifentanil
Ultiva
Monitored Anesthesia Care
Sedation

Bronchoscopy
Lung cancer
Mediastinal node
Cancer staging
Anesthesia
Remote location

Additional relevant MeSH terms:

Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Anesthetics
Remifentanil
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on June 18, 2013

Safety Evaluation of Dexmedetomidine for EBUS-TBNA (EBUSed)