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

Baylor College of Medicine

Status: Completed

Conditions: Mediastinal Masses; Mediastinal Lymphadenopathies; Hilar Lymphadenopathies

Study type: Observational

Funder types: Other

Identifiers

NCT01430962

H-27545

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

149 participants in 2 patient groups

General Anesthesia

Description:

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

Description:

Patients will receive moderate sedation given by the physician performing EBUS with a combination of Versed and Fentanyl per hospital protocol.