Background and Study Aims: Adequate sedation of the patient is required for
diagnostic and therapeutic endoscopic retrograde cholangiopancreatography
(ERCP). The anesthetic propofol, with its shorter half-life, affording bett
er control, offers an alternative to the benzodiazepine midazolam. The aim
of this randomized, controlled, unblinded study was to compare prospectivel
y the quality of sedation under propofol and midazolam in patients undergoi
ng ERCP.
Patients and Methods: A total of 80 patients were randomized to sedation wi
th propofol alone (n = 40) or midazolam alone (n = 40). Blood pressure, pul
se, and oxygen saturation were measured. Midazolam was given by the endosco
pist and titrated to the patients' response during ERCP, to a maximum dose
of 15 mg per patient. In the propofol group an anesthetist was present to a
dminister the propofol and to observe the patient. Standardized testing pro
cedures (Steward score, Trieger test) were used to determine the length of
postendoscopy recovery time. Efficacy of sedation was assessed by investiga
tors and patients, using scoring systems.
Results: Complete ERCP and adequate sedation was possible in 80% of patient
s (32 out of 40) with midazolam, and in 97.5% of patients (39 out of 40) wi
th propofol (P < 0.01). The average propofol induction dose was 1.24 mg/kg
body weight, with maintenance requiring a mean dose of 9 mg/kg body weight
per hour, or the equivalent of 354 mg in total. The average dose of midazol
am administered was 0.12 mg/kg body weight; the total dose averaged 8 mg. R
ecovery time in the propofol patients was significantly shorter (P < 0.01).
The investigators (P < 0.01) and the patients (P < 0.05) both judged the q
uality of sedation to be better in the propofol group. There were no differ
ences in blood pressure, pulse, or oxygen saturation between the two groups
. One patient in the propofol group (79 years old) suffered a protracted ap
neic phase accompanied by hypotension that was managed by manual ventilatio
n and drug therapy, and led to no complications.
Conclusions: Propofol proves to be an excellent sedative for ERCP and shows
a shorter recovery time than midazolam. Because of the narrow therapeutic
window, we recommend close patient monitoring.