Efficacy of midazolam- versus propofol-based sedations by non-anesthesiologists during therapeutic endoscopic retrograde cholangiopancreatography in patients aged over 80 years.

ABSTRACT

BACKGROUND AND AIM: As society ages, the need for endoscopic retrograde cholangiopancreatography (ERCP) is increasing. This prospective comparative study evaluated the safety and efficacy of midazolam- versus propofol-based sedations by non-anesthesiologists during therapeutic ERCP in patients over 80 years of age. METHODS: A total of 100 patients over 80 years of age who required therapeutic ERCP were enrolled and randomly received midazolam + fentanyl (MF group) or propofol + fentanyl (PF group) sedation. Endoscopic sedation was titrated to a moderate level and carried out by trained registered nurses. Main outcome measurements were sedation safety in terms of cardiopulmonary components and efficacy measured on a 10-point visual analogue scale (VAS). RESULTS: Regarding safety, hypoxia occurred in seven (14%) in the MF group and in eight patients (16%) in the PF group (P = 0.779). Increased O2 supply was more frequent in the PF group (32% vs 42%), albeit not significantly so. There were no differences in the frequency of hypotension, bradycardia or tachycardia between the two groups. Mean VAS score for overall satisfaction with sedation by patients, endoscopists, and nurses and the scores for pain during the procedures were not different between the two groups. There was no significant difference in the procedure outcomes or rate of ERCP-related complications. CONCLUSIONS: There were no significant differences of safety and efficacy between midazolam- and propofol-based sedation in patients over 80 years of age. Increased O2 supply was more frequent in the propofol group, but the prevalence of hypoxia did not differ significantly.