Propofol versus midazolam for conscious sedation guided by processed EEG during endoscopic retrograde cholangiopancreatography: A prospective, randomized, double-blind study

Background and Study Aims: Endoscopic retrograde cholangiopancreatography ( ERCP) is a complex procedure, which requires appropriate sedation. The aim of this prospective, randomized, double-blind study was to compare the qual ity and characteristics of sedation with midazolam or propofol in patients undergoing ERCP. Patients and Methods: A total of 32 patients undergoing ERCP were randomly allocated for sedation with propofol (n=15) or midazolam (n=17), Blood pres sure, heart rate, and O-2 saturation were monitored, Sedation was maintaine d at near constant levels by use of the spectral edge frequency (SEF) techn ique, an EEG-based method for measuring the depth of sedation. Clinical var iables, patient cooperation, time to recovery, and amnesia served as outcom e variables. Results: There was no significant difference between the two study groups i n patient characteristics. The "target SEF" was 13.6+/-0.7 Hz for the propo fol group and 14.8+/-1.1 Hz for the midazolam group (n.s.). The only clinic al parameter with a significant difference between the groups was the perce nt of time in which the heart rate deviated more than 20% from baseline for at least 2 minutes, i.e. 14.6+/-2.0% for propofol and 48.2+/-38.0% for mid azolam (P<0.01). Patient cooperation was better in the propofol group than in the midazolam group (full cooperation, 13/15 vs. 1/17, respectively; P<0 .001). Patient recovery was significantly quicker in the propofol group (P< 0.001). The degree of amnesia was similar in both groups; no patient in eit her group remembered details of the procedure. Conclusions: ERCP is better tolerated by patients sedated with propofol com pared with midazolam, with a shorter recovery time and lesser hemodynamic s ide effects. Propofol should be considered to be the sedative drug of choic e for ERCP.