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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01430962
Acronym
EBUS-GA-MS
Enrollment
149
Registered
2011-09-09
Start date
2011-11-30
Completion date
2014-02-28
Last updated
2015-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hilar Lymphadenopathies, Mediastinal Lymphadenopathies, Mediastinal Masses

Keywords

EBUS, mediastinal lymph nodes, mediastinal masses, anesthesia, moderate sedation

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.

Interventions

None listed

Sponsors

Baylor College of Medicine
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Diagnostic Yield24 months

Secondary

MeasureTime frame
Complications rate24 months
Time to recovery from anesthesia24 months
Tolerance to procedure24 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026