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Alpha-2 Adrenergic Agonist

Dexmedetomidine for Lung Cancer (EBUSed Trial)

Phase 4
Waitlist Available
Led By Olivier Verdonck, MD
Research Sponsored by Maisonneuve-Rosemont Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patient followed for the entire duration of ebus-tbna (avg. 40 min) and until discharge of pacu (1 day total, ambulatory basis)
Awards & highlights

EBUSed Trial 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.

Eligible Conditions
  • Lung Cancer

EBUSed Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patient followed for the entire duration of ebus-tbna (avg. 40 min) and until discharge of pacu (1 day total, ambulatory basis)
This trial's timeline: 3 weeks for screening, Varies for treatment, and patient followed for the entire duration of ebus-tbna (avg. 40 min) and until discharge of pacu (1 day total, ambulatory basis) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Major adverse events
Secondary outcome measures
Aldrete scores in the post anesthesia care unit
Coughing episodes
Dexmedetomidine
+9 more

Side effects data

From 2020 Phase 4 trial • 798 Patients • NCT02004613
57%
Clinically important hypotension
9%
Clinically important bradycardia
1%
infection
1%
stroke
1%
Atelectasis
1%
Hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Dexmedetomidine

EBUSed Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DexmedetomidineExperimental Treatment1 Intervention
Group II: RemifentanilActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine
FDA approved

Find a Location

Who is running the clinical trial?

Maisonneuve-Rosemont HospitalLead Sponsor
99 Previous Clinical Trials
36,263 Total Patients Enrolled
Olivier Verdonck, MDPrincipal InvestigatorUniversité de Montréal

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~4 spots leftby May 2025