Implementation of sedation guidelines in clinical practice in Italy: results of a prospective longitudinal multicenter study.

BACKGROUND AND STUDY AIMS

Following publication in 2000 of the Italian Guidelines for Sedation in Digestive Endoscopy, the authors carried out a dissemination program and an audit of the impact of the Guidelines in clinical practice. The primary aim was to evaluate any changes in sedation methods at the start of and during the study period (at 0, 6, and 12 months). Secondary study aims were detailed analyses of endoscopies regarding sedation, complications, and patient satisfaction.

PATIENTS AND METHODS

The prospective, observational, multicenter study was commenced in 60 centers (31 first- and 29 second-level) which opted to have seminars on the Guidelines; results concerning sedation practices in relation to endoscopic procedure, complications, and patient satisfaction were recorded at the start of the study (phase 0) and at 6 and 12 months. Over a 1-year period, 5261 sedated and unsedated patients undergoing endoscopic procedures were enrolled (with data collection between December 1999 and June 2002). The results were analyzed using the chi-squared test.

RESULTS

Data were available for all three assessment time points from 29 of the 60 centers. The sedation rate, between phase 0 and 2, increased by 12.75% in first-level centers and 0.73% in second-level centers with midazolam use increasing from 34% to 41%. For colonoscopy, sedation usage increased from 52% to 56%. Adverse events occurred in 0.47% of the patients, without long-term sequelae or death, and patient satisfaction was only slightly, but not significantly higher with sedation (90.4% of sedated patients were "very satisfied" vs. 87% of unsedated patients who were "satisfied"), but the examination was more likely to be complete in sedated patients and this difference was statistically significant ( P < 0.001).

CONCLUSIONS

We conclude that if sedation is used as recommended by the Guidelines, it is possible to control clinical risk by using high quality endoscopic procedures.