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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

September 7, 2011
October 24, 2011
October 2011
September 2013   (final data collection date for primary outcome measure)
Diagnostic Yield [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01430962 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Endobronchial Ultrasound Guided Transbronchial Needle Aspiration Performed Under General Anesthesia Versus Moderate Sedation
Randomized Controlled Trial Comparing Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) Performed Under General Anesthesia Versus Conscious Sedation

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Mediastinal Lymphadenopathies
  • Mediastinal Masses
  • Hilar Lymphadenopathies
Not Provided
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Roberto F. Casal, MD 713-794-8066 casal@bcm.edu
United States
 
NCT01430962
H-27545
No
Roberto Casal, Baylor College of Medicine
Baylor College of Medicine
Not Provided
Principal Investigator: Roberto F. Casal, MD Baylor College of Medicine- Michael E. DeBakey VA Medical Center
Baylor College of Medicine
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP