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

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Abstract

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. (Gastrointest Endosc 1999;49:677-83.)

Section snippets

PATIENTS AND METHODS

Two hundred consecutive adult patients admitted for routine diagnostic and therapeutic ERCP were randomly assigned by a computer-generated list for sedation with either propofol (mean age 63.6 ± 23.3 years, range 30 to 88 years, 58 women, 42 men) or midazolam (mean age 61.2 ± 20.5 years, range 28 to 80 years; 60 women, 40 men). According to the American Society of Anaesthesiology (ASA) physical status classification, the majority of the patients of both study groups (midazolam group, n = 67,

RESULTS

In the midazolam group, two patients were excluded after randomization, one because it was impossible to cannulate the papilla because of infiltration by pancreatic carcinoma and the other due to the unexpected finding of an esophagogastric carcinoma that hindered the passage of the endoscope. In the propofol group, one patient was excluded because of obstruction of the duodenal bulb by extramural compression due to a large carcinoma of the pancreatic head that rendered passage of the

DISCUSSION

This first prospective randomized study demonstrates that intravenous propofol is more effective than midazolam for sedation during ERCP and does not increase the risk for clinically relevant side effects if patient monitoring is adequate.

ERCP and its related procedures were traditionally performed under conscious sedation. The need for proper sedation during ERCP is particularly obvious if technically demanding procedures such as sphincterotomy or transpapillary stent placement are performed.

Acknowledgements

We thank B. Braden, MD, and C. F. Dietrich, MD, who carried out the intravenous sedation during the examinations.

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    Reprint requests: Till Wehrmann, MD, Department of Internal Medicine II, J.W. Goethe University Hospital, Theodor Stern Kai 7, 60590 Frankfurt am Main, Germany.

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