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
Information provided by (Responsible Party):
Roberto Casal, Baylor College of Medicine
First received: September 7, 2011
Last updated: October 24, 2011
Last verified: October 2011
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.
||Time Perspective: Prospective
||Randomized Controlled Trial Comparing Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) Performed Under General Anesthesia Versus Conscious Sedation
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:
| Study Start Date:
| Estimated Primary Completion Date:
||September 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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Adult individuals with suspected mediastinal or hilar lymphadenopathies or masses referred for endobronchial ultrasound-guided biopsy.
- 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
- 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
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
|Michael E. DeBakey VA Medical Center
|Houston, Texas, United States, 77030 |
|Contact: Roberto F Casal, MD 713-794-8066 |
Baylor College of Medicine
||Roberto F. Casal, MD
||Baylor College of Medicine- Michael E. DeBakey VA Medical Center
||Roberto Casal, Assistant Professor of Medicine, Baylor College of Medicine
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 7, 2011
||October 24, 2011
||United States: Institutional Review Board
Keywords provided by Baylor College of Medicine:
mediastinal lymph nodes
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 20, 2014
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents