Sedation with propofol for interventional endoscopy by trained nurses in high-risk octogenarians: a prospective, randomized, controlled study.

BACKGROUND AND STUDY AIMS: Sedation with the short-acting anesthetic agent propofol has shown several advantages, particularly in interventional endoscopy. So far, however, there are no valid data on the safety of nurse-administered propofol sedation (NAPS) during interventional endoscopy in elderly high-risk patients. PATIENTS AND METHODS: A total of 150 patients aged > 80 years with high comorbidity were randomized to receive midazolam plus meperidine (n = 75) or propofol alone (n = 76) for sedation during endoscopic retrograde cholangiopancreatography (ERCP), endoscopic ultrasound (EUS), or double-balloon endoscopy (DBE). Sedation was supervised by a trained nurse and a trained physician both of whom were not involved in the endoscopic procedure. Vital signs were continuously monitored as well as patient cooperation and tolerance. Mortality and morbidity at 30 days was analyzed.
RESULTS: The overall cardiopulmonary complication rate was 16 % in the midazolam group and 23.7 % in the propofol group ( P > 0.05). The mean decline in oxygen saturation (initial vs. lowest O (2) saturation) and the mean decline of blood pressure (initial vs. lowest blood pressure) were significantly greater with propofol (7 % +/- 3 % vs. 4 % +/- 2 % [ P < 0.05] and 10 % +/- 2 % vs. 8 % +/- 2 %, respectively [ P < 0.05]). No procedure had to be interrupted due to serious adverse events. Patient cooperation was statistically significantly better in the propofol group (7 +/- 2 vs. 5 +/- 2 points). Patients sedated with propofol showed a significantly lower oxygen saturation rate during recovery time (8 % vs. 28 %; P < or = 0.01).
CONCLUSION: NAPS during interventional endoscopy is as safe as midazolam/pethidine sedation even in high-risk patients aged > 80 years.

RCT Entities:   Population Interventions Outcomes