Know Cancer

or
forgot password

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


Phase 4
18 Years
75 Years
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

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


See above


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Major adverse events

Outcome Description:

Bradypnea,apnea, oxygen desaturation, hypotension, hypertension, heart rate <45 beats per minute, heart rate ≥120 beats per minute

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Olivier Verdonck, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Université de Montréal

Authority:

Canada: Ethics Review Committee

Study ID:

11021

NCT ID:

NCT01381627

Start Date:

June 2011

Completion Date:

June 2013

Related Keywords:

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

Name

Location