The efficacy of non-anesthesiologist-administered propofol sedation with a target-controlled infusion system during double-balloon endoscopic retrograde cholangiopancreatography

Background: The sedation method used during double-balloon endoscopic retrograde cholangiopancreatography (DB-ERCP) differs among countries and/or facilities, and there is no established method. This study aimed to evaluate the efficacy of non-anesthesiologist-administered propofol (NAAP) sedation using a target-controlled infusion (TCI) systemduring DB-ERCP. Methods: This retrospective study was conducted between May 2017 and December 2020 at an academic center. One hundred and fifty-six consecutive patients who underwent DB-ERCP were sedated by gastroenterologists using diazepam (n=77) or propofol with a TCI system (n=79), depending on the period. The primary endpoint was a comparison of poor sedation rates between the two groups. Poor sedation was defined as a condition requiring the use of other sedative agents or discontinuation of the procedure. Secondary endpoints were sedation-related adverse events and risk factors for poor sedation. Results: Poor sedation occurred significantly more often in the diazepam sedation group (diazepam sedation, n=12 [16%] vs. propofol sedation, n=1 [1%]; P=0.001). Vigorous body movements (3 or 4) (diazepam sedation, n=40 [52%] vs. propofol sedation, n=28 [35%]; P=0.038) and hypoxemia (< 85%) (diazepam sedation, n=7 [9%] vs. propofol sedation, n=1 [1%]; P=0.027) occurred significantly more often in the diazepam sedation group. In the multivariate analysis, age < 70 years old (OR, 10.26; 95% CI, 1.57-66.98; P=0.015), BMI>25 kg/m2 (OR, 11.96; 95% CI, 1.67-85.69; P=0.014), and propofol sedation (OR, 0.06; 95% CI, 0.01-0.58; P=0.015) were associated factors for poor sedation. Conclusions: NAAP sedation with the TCI system during DB-ERCP was safer and more effective than diazepam sedation.