title: Randomized trial of endobronchial ultrasound-guided transbronchial needle aspiration under general anesthesia versus moderate sedation.
abstract: BACKGROUND
  Data about the influence of the type of sedation on yield, complications, and tolerance of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) are based mostly on retrospective studies and are largely inconsistent.
  
  
  OBJECTIVE
  To determine whether the type of sedation influences the diagnostic yield of EBUS-TBNA, its complication rates, and patient tolerance.
  
  
  METHODS
  Patients referred for EBUS-TBNA were randomized (1:1) to undergo this procedure under general anesthesia (GA) or moderate sedation (MS). Pathologists were blinded to group allocation.
  
  
  RESULTS
  The main outcome was "diagnostic yield," defined as the percentage of patients for whom EBUS-TBNA rendered a specific diagnosis. One hundred and forty-nine patients underwent EBUS-TBNA, 75 under GA and 74 under MS. Demographic and baseline clinical characteristics were well balanced. Two hundred and thirty-six lymph nodes (LNs) and six masses were sampled in the GA group (average, 3.2 ± 1.9 sites/patient), and 200 LNs and six masses in the MS group (average, 2.8 ± 1.5 sites/patient) (P = 0.199). The diagnostic yield was 70.7% (53 of 75) and 68.9% (51 of 74) for the GA group and MS group, respectively (P = 0.816). The sensitivity was 98.2% in the GA group (confidence interval, 97-100%) and 98.1% in the MS group (confidence interval, 97-100%) (P = 0.979). EBUS was completed in all patients in the GA group, and in 69 patients (93.3%) in the MS group (P = 0.028). There were no major complications or escalation of care in either group. Minor complications were more common in the MS group (29.6 vs. 5.3%) (P < 0.001). Most patients stated they "definitely would" undergo this procedure again in both groups (P = 0.355).
  
  
  CONCLUSIONS
  EBUS-TBNA performed under MS results in comparable diagnostic yield, rate of major complications, and patient tolerance as under GA. Future prospective multicenter studies are required to corroborate our findings. Clinical trial registered with www.clinicaltrials.gov (NCT 01430962).
authors.affiliation: 1 Department of Pulmonary and Critical Care Medicine and.
authors.forename: Roberto F
authors.initials: RF
authors.lastname: Casal
authors.forename: Donald R
authors.initials: DR
authors.lastname: Lazarus
authors.forename: Kristine
authors.initials: K
authors.lastname: Kuhl
authors.forename: Graciela
authors.initials: G
authors.lastname: Nogueras-González
authors.forename: Sarah
authors.initials: S
authors.lastname: Perusich
authors.forename: Linda K
authors.initials: LK
authors.lastname: Green
authors.forename: David E
authors.initials: DE
authors.lastname: Ost
authors.forename: Mona
authors.initials: M
authors.lastname: Sarkiss
authors.forename: Carlos A
authors.initials: CA
authors.lastname: Jimenez
authors.forename: Georgie A
authors.initials: GA
authors.lastname: Eapen
authors.forename: Rodolfo C
authors.initials: RC
authors.lastname: Morice
authors.forename: Lorraine
authors.initials: L
authors.lastname: Cornwell
authors.forename: Sheila
authors.initials: S
authors.lastname: Austria
authors.forename: Amir
authors.initials: A
authors.lastname: Sharafkanneh
authors.forename: Rolando E
authors.initials: RE
authors.lastname: Rumbaut
authors.forename: Horiana
authors.initials: H
authors.lastname: Grosu
authors.forename: Farrah
authors.initials: F
authors.lastname: Kheradmand
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000768:Anesthesia, General; D044963:Biopsy, Fine-Needle; D016292:Procedural Sedation; D019160:Endosonography; D005260:Female; D006801:Humans; D061705:Image-Guided Biopsy / Q000379:methods*; D008198:Lymph Nodes / Q000000981:diagnostic imaging / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000000981:diagnostic imaging / Q000473:pathology*; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D021701:Sentinel Lymph Node Biopsy / Q000379:methods*
keywords: anesthesia; endobronchial ultrasound; interventional pulmonology; moderate sedation