The effect of sedation on the quality of upper gastrointestinal endoscopy: an investigator-blinded, randomized study comparing propofol with midazolam

Background and study aims: Sedation with propofol is associated with a high acceptance rate in upper gastrointestinal endoscopy. So far, however, there are no valid data on whether the use of propofol can increase the general quality of the endoscopic examination. Patients and methods: A total of 60 patients referred for upper gastrointestinal endoscopy were randomized to receive sedation with either midazolam (n = 30) or propofol (n = 30). The maximum dosages permitted were 5 mg of midazolam and 500 mg of propofol. The examinations were recorded on videotapes, and the quality of upper endoscopy was assessed by videotape analysis by three experienced endoscopists who were all blinded to patient data and the medications used for sedation. A score sheet was used with 18 assessment items that each represented a step of upper gastrointestinal endoscopy and a global score for the entire examination. A scale ranging from 1 (excellent) to 6 (very poor) was used. Data were analyzed on an intention-to-investigate basis: inability to perform the procedure because of a patient's intolerance of the procedure, for example, was scored as 6 (i.e. very poor). Results: Patients in the two groups were well matched with respect to demographic and clinical data. Four patients in the midazolam group could not be adequately examined. The median dosage used for sedation was 5 mg midazolam (range 2 - 5 mg) and 160 mg propofol (range 70-320 mg). When assessments by all three blinded examiners were added together, propofol sedation was found to result in significantly better scores for all parameters except for the assessments of "Z-line/cardia", "duodenal bulb", and "duodenal folds" (all P < 0.05, Mann-Whitney U test). Conclusion: Sedation with propofol might increase the quality of upper endoscopy. This finding may have a significant impact on the selection of the type of sedation, not only in terms of increasing patients' acceptance of the procedure, but also for improving the diagnostic accuracy of upper gastrointestinal endoscopy.