Recruiting

Dexmedetomidine

Sponsor:

Maisonneuve-Rosemont Hospital

Code:

NCT01381627

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Remifentanil

Dexmedetomidine

Study Details

Brief 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.

Conditions

Lung Cancer

Study ID

NCT01381627

Start date

Jun, 2011

Status verified date

Jun, 2011

Completion date

Jun, 2013

Anticipated

Primary completion date

Jun, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Remifentanil

experimental: Dexmedetomidine

Interventions

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.

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.

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Locations

Hôpital Maisonneuve-Rosemont

Recruiting

Montreal, Quebec, Canada, H1T 2M4

More Information

Sponsor

Maisonneuve-Rosemont Hospital

Last update posted

Feb 28, 2013

Last verified

Jun, 2011

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Maisonneuve-Rosemont Hospital on 2013-02-28.