Efficacy and safety of intravenous propofol sedation during routine ERCP: a prospective, controlled study.

BACKGROUND: Adequate patient sedation is mandatory for diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP). The short-acting anesthetic propofol offers certain potential advantages for endoscopic procedures, but controlled studies proving its superiority over benzodiazepines for ERCP are lacking.

METHODS: During a 6-month period 198 consecutive patients undergoing routine ERCP randomly received either midazolam (n = 98) or propofol (n = 99) for sedation. Vital signs (heart rate, blood pressure, oxygen saturation) were continuously monitored and procedure-related parameters, the recovery time and quality (recovery score) as well as the patient's cooperation and tolerance of the procedure (visual analog scales) were prospectively assessed.

RESULTS: Patients receiving propofol or midazolam were well matched with respect to demographic and clinical data, ERCP findings, and the performance of associated procedures. Propofol caused a more rapid onset of sedation than midazolam (p < 0.01). Clinically relevant changes in vital signs were observed at comparable frequencies with temporary oxygen desaturation occurring (< 85 %) in 6 patients in the propofol group and 4 patients receiving midazolam (not significant). However, an episode of apnea had to be managed by mask ventilation via an ambu bag (lasting 8 minutes) in one of the patients receiving propofol sedation. Mean recovery times as well as the recovery scores were significantly shorter with propofol (p < 0. 01). Propofol provided significantly better patient cooperation than midazolam ( p < 0.01), but procedure tolerability was rated the same by both groups of patients (not significant).

CONCLUSIONS: Intravenous sedation with propofol for ERCP is (1) more effective than sedation with midazolam, (2) safe under adequate patient monitoring, and (3) associated with a faster postprocedure recovery.