Safety Evaluation of Dexmedetomidine for EBUS-TBNA

Lung Cancer Clinical Trial

— EBUSed  

Official title:

Safety Evaluation of Dexmedetomidine Monitored Anesthesia Care for Endobronchial Ultrasound-guided Transbronchial Needle Aspiration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01381627
• Other study ID #: 11021
• Status: Recruiting
• Phase: Phase 4
• First received: June 21, 2011
• Last updated: February 27, 2013
• Start date: June 2011
• Est. completion date: June 2013

Study information

• Verified date: June 2011
• Source: Maisonneuve-Rosemont Hospital
• Contact: Olivier Verdonck, MD
• Phone: 1-514-252-3426
• Email: overdonck[@]gmail.com
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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.

Description:

See above

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 a2-adrenoreceptor agonist or antagonist within 14 days.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Hôpital Maisonneuve-Rosemont	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse events	Bradypnea,apnea, oxygen desaturation, hypotension, hypertension, heart rate <45 beats per minute, heart rate =120 beats per minute	Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis)	Yes
Secondary	Vocal cord movement	Vocal cord movement before fiberscope passage	Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis)	No
Secondary	Sedation scores	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.	Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis)	No
Secondary	Aldrete scores in the post anesthesia care unit	Aldrete score immediately after removal of fiberscope, time for Aldrete score equal or superior to 9 (assesed at 5 minute intervals).	Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis)	No
Secondary	Nausea and vomiting		Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis)	No
Secondary	Cumulative dose of remifentanil or dexmedetomidine		Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis)	No
Secondary	Total dose of lidocaine	Cumulative dose of lidocaine administered by the endoscopist	Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis)	No
Secondary	Total dose of vasopressor	Cumulative dose of vasopressor administered	Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis)	No
Secondary	Coughing episodes	Coughing episodes throughout the EBUS-TBNA procedure	Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis)	No
Secondary	Endoscopist satisfaction	Endoscopist global satisfaction score based on a 4-point Likert scale	Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis)	No
Secondary	Recall	Recall evaluation once Aldrete score superior to 9 in post anesthesia care unit. Evaluation based on a 4-point Likert scale	Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis)	No
Secondary	Pain associated with the procedure (VAS)	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 followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis)	No
Secondary	Patient satisfaction	Global patient satisfaction associated with the procedure. Score based on a 5 point Likert scale. Measured before patient leaves the post anesthesia care unit.	Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis)	No