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

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ClinicalTrials.gov Identifier: NCT01430962
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : July 23, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Mediastinal Lymphadenopathies Mediastinal Masses Hilar Lymphadenopathies

Study Design

Study Type : Observational
Actual Enrollment : 149 participants
Time Perspective: Prospective
Official Title: Randomized Controlled Trial Comparing Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) Performed Under General Anesthesia Versus Conscious Sedation
Study Start Date : November 2011
Primary Completion Date : July 2013
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.


Outcome Measures

Primary Outcome Measures :
  1. Diagnostic Yield [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Complications rate [ Time Frame: 24 months ]
  2. Time to recovery from anesthesia [ Time Frame: 24 months ]
  3. Tolerance to procedure [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01430962


Locations
United States, Texas
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: September 9, 2011    Key Record Dates
Last Update Posted: July 23, 2015
Last Verified: July 2015

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

Additional relevant MeSH terms:
Lymphadenopathy
Lymphatic Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs