Endobronchial Ultrasound Guided Transbronchial Needle Aspiration Performed Under General Anesthesia Versus Moderate Sedation (EBUS-GA-MS)
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.
|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|
- Diagnostic Yield [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||November 2011|
|Study Completion Date:||February 2014|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
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.
Patients will receive moderate sedation given by the physician performing EBUS with a combination of Versed and Fentanyl per hospital protocol.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430962
|United States, Texas|
|Michael E. DeBakey VA Medical Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Roberto F. Casal, MD||Baylor College of Medicine- Michael E. DeBakey VA Medical Center|