Endobronchial Ultrasound Guided Transbronchial Needle Aspiration Performed Under General Anesthesia Versus Moderate Sedation (EBUS-GA-MS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Baylor College of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Roberto Casal, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01430962
First received: September 7, 2011
Last updated: October 24, 2011
Last verified: October 2011
  Purpose

The purpose of the study is to determine if there are any differences in yield or safety of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) (a type of bronchoscopy with biopsy) performed under general anesthesia versus moderate sedation.


Condition
Mediastinal Lymphadenopathies
Mediastinal Masses
Hilar Lymphadenopathies

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Randomized Controlled Trial Comparing Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) Performed Under General Anesthesia Versus Conscious Sedation

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Diagnostic Yield [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications rate [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Time to recovery from anesthesia [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Tolerance to procedure [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
General Anesthesia
Patients will receive Total Intravenous Anesthesia (TIVA) with a combination of Propofol, Ketamine and neuromuscular blockade by anesthesia. Either an LMA or an ETT will be used to secure airway.
Moderate Sedation
Patients will receive moderate sedation given by the physician performing EBUS with a combination of Versed and Fentanyl per hospital protocol.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult individuals with suspected mediastinal or hilar lymphadenopathies or masses referred for endobronchial ultrasound-guided biopsy.

Criteria

Inclusion Criteria:

  • All patients over the age of 18, evaluated by pulmonary physician that require EBUS TBNA for sampling of hilar and/or mediastinal lymphadenopathies or masses
  • Patients should be considered eligible to undergo either CS or GA, without contraindications for either one of them, based on the assessment by the pulmonologist who will perform EBUS-TBNA

Exclusion Criteria:

  • Pregnancy or breastfeeding women
  • Patients deemed poor candidates for general anesthesia by the evaluating physician (e.g., severe coronary artery disease, COPD with FEV1 < 1 liter, uncontrolled hypertension, increased intracranial pressure, reaction to anesthetics)
  • Previous reaction to medications routinely used in conscious sedation
  • Patients with history of intolerance to either general anesthesia or conscious sedation
  • Dementia or other severe cognitive impairment causing inability to understand or consent to the procedure and study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430962

Contacts
Contact: Roberto F. Casal, MD 713-794-8066 casal@bcm.edu

Locations
United States, Texas
Michael E. DeBakey VA Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Roberto F Casal, MD    713-794-8066      
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Roberto F. Casal, MD Baylor College of Medicine- Michael E. DeBakey VA Medical Center
  More Information

Publications:
Responsible Party: Roberto Casal, Assistant Professor of Medicine, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01430962     History of Changes
Other Study ID Numbers: H-27545
Study First Received: September 7, 2011
Last Updated: October 24, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
EBUS
mediastinal lymph nodes
mediastinal masses
anesthesia
moderate sedation

Additional relevant MeSH terms:
Lymphatic Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014