Randomized Trial of Endobronchial Ultrasound–guided Transbronchial Needle Aspiration under General Anesthesia versus Moderate Sedation

Abstract

Rationale: 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.Objectives: 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.Measurements and Main Results: The main outcome was "diagnostic yield," defined as the percentage of patients for whom EBUS-TBNA rendered a specific diagnosis. One hundred and fortynine 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 6 1.9 sites/ patient), and 200 LNs and six masses in the MS group (average, 2.8 6 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).

Endobronchial ultrasound-guided transbronchial needle aspiration under conscious sedation with meperidine and midazolam

“…Our data prove that EBUS-TBNA under conscious sedation is associated with extremely high patient satisfaction, in agreement with previous reports, including studies that used different agents for conscious sedation [16,24,27].…”

“…A recent randomized trial on 149 patients is in agreement with our experience since it concluded that EBUS-TBNA performed under moderate sedation results in comparable diagnostic yield, rate of major complications, and patient tolerance as under general anesthesia [24]. …”

“…Our results are also supported by the recent guidelines for the acquisition and preparation of EBUS-TBNA specimens [13,24] underlining that the type of anesthesia seems to have no influence on the diagnostic yield of EBUS-TBNA. Furthermore, the same guidelines remark the importance of the number of aspirates per lymph node for the diagnostic yield of the specimen [13], and probably the low percentage of specific diagnosis in our study is due to the necessity to perform more passes for lymph node rather than to the type of sedation.…”

“…sum of true positive and true negative cases) was observed in a percentage (55%) lower than several data in literature [22][23][24][25]. Better diagnostic performance was reported by Casal et al (69% diagnostic yield) but all the procedures were carried out by the same expert operator [24]. A diagnostic yield of 66% was recorded by Yarmus et al, but all operators had similar and advanced expertise [25].…”

Discomfort during bronchoscopy performed after endobronchial intubation with fentanyl and midazolam: a prospective study

“…A previous report showed that EBUS-TBNA performed under moderate sedation with a combination of fentanyl and midazolam resulted in comparable diagnostic yield, major complication rate and patient tolerance values compared with those who received general anesthesia (13). EBUS-TBNA with endobronchial intubation was performed in 24 patients in this post hoc analysis.…”