Safety Evaluation of Dexmedetomidine for EBUS-TBNA

NCT01381627 | Unknown Phase 4 DMC

• 1 other identifier: 11021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (12)

• Vocal cord movement

  Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis)

• Sedation scores

  Patient followed for the entire duration of EBUS-TBNA (avg. 40 min) and until discharge of PACU (1 day total, ambulatory basis)

• Aldrete scores in 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)

• 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)

• 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)

Study Arms (2)

Remifentanil

ACTIVE COMPARATOR

Drug: Remifentanil

Dexmedetomidine

EXPERIMENTAL

Drug: Dexmedetomidine

Interventions

Remifentanil DRUG

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.

Also known as: Ultiva

Remifentanil

Dexmedetomidine DRUG

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.

Also known as: Precedex

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead

Study Sites (1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

Related Publications (1)

• St-Pierre P, Tanoubi I, Verdonck O, Fortier LP, Richebe P, Cote I, Loubert C, Drolet P. Dexmedetomidine Versus Remifentanil for Monitored Anesthesia Care During Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration: A Randomized Controlled Trial. Anesth Analg. 2019 Jan;128(1):98-106. doi: 10.1213/ANE.0000000000003633.

  PMID: 29958220 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Remifentanil; Dexmedetomidine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles

Study Officials

• Olivier Verdonck, MD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier Verdonck, MD

CONTACT

1-514-252-3426; overdonck@gmail.com

Nadia Godin, RN

CONTACT

1-514-252-3400; ngodin.hmr@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: June 27, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 28, 2013

Record last verified: 2011-06

Locations

CA (1)