Aims
Endoscopic ultrasound (EUS) is a second-level endoscopic procedure with substantially greater procedural complexity than standard diagnostic endoscopy, typically requiring deeper and longer sedation. However, an optimal sedation strategy in this setting has not yet been established. This study evaluated the safety of non-anesthesiologist-administered propofol sedation (NAPS) for diagnostic EUS across ASA risk classes, focusing on sedation-related adverse events (AEs).
Methods
All consecutive diagnostic EUS procedures performed between January 2021 and May 2024 were included. Sedation involved balanced deep sedation using fentanyl, midazolam, and propofol administered by trained endoscopy nurses in accordance with ESGE/ESGENA guidelines. AEs were classified according to World Society of Intravenous Anesthesia definitions.
Results
A total of 1134 diagnostic EUS procedures performed under NAPS were analyzed. The majority were biliopancreatic (73.0%), followed by esophagogastroduodenal (21.2%) and rectal EUS (5.8%). Tissue sampling via FNB/FNA was performed in 21.3% of cases, with a diagnostic accuracy of 93%. Median dosages were 260 mg propofol, 70 μg fentanyl, and 1.6 mg midazolam, with a median procedure time of 34 minutes (range 10–132). Sedation-related AEs occurred in 95 cases (8.4%): 31 (2.7%) mild, 58 (5.1%) moderate, and 6 (0.5%) severe. All AEs were managed by endoscopy staff without the need for anesthesiologist assistance. Moderate AEs included hypotension requiring fluids (1.5%), bradycardia <60 bpm (3.4%), and desaturation >30 seconds (0.3%). Severe AEs included bradycardia <40 bpm treated with atropine (0.4%) and severe desaturation requiring assisted ventilation (0.2%). No AEs had clinically relevant consequences; only two procedures were discontinued, and no patient required hospitalization or extended care.
Multivariate analysis demonstrated that age (OR 1.14; p<0.001) and ASA class (OR 7.17; p<0.001) were the only independent predictors of AE risk. ASA III status was associated with a 1.47-fold higher relative risk compared with ASA I–II. BMI, number of comorbidities, Charlson Comorbidity Index (CCI), drug dosages, and procedure timewere not associated with AEs risk. ASA III patients accounted for 359 procedures (31.8%) and, among them, adverse events comprised 41% (39/95) of all AEs, with the majority (24/39, 61.5%) occurring in patients older than 65 years. The distribution of AEs severity in ASA III patients, was as follows: mild in 2.5% (9/359), moderate in 7.5% (27/359), and severe in 0.8% (3/359)
Risk stratification based on the combination of age and ASA status identified three categories with progressively increasing AEs incidence: low (ASA I–II and <65 years), intermediate (ASA I–II and >65 years or ASA III and <65 years), and high risk (ASA III and >65 years). This model showed a significant correlation with AEs occurrence (p=0.029), with a stepwise increase in AEs rates across groups—5.6%, 9.2%, and 12.3%, respectively.
Conclusions
NAPS demonstrated a favorable safety profile across all ASA classes, with low rates of clinically relevant AEs. The highest AEs risk was observed in ASA III patients older than 65 years. Although these events were predominantly minor to moderate in severity, more caution could be take in this subgroup of patients.