An instrument to predict endoscopy tolerance: a prospective randomized study.

Our purpose in this study was to determine if the use of an instrument developed by our group to direct sedation choice improves patient satisfaction with endoscopy sedation compared to standard sedation practice. After 200 enrollments, data were available for 194 patients who completed the study. There were nine cases of dissatisfaction: five (5%) in the control group and four (4%) in the intervention group (P = 0.78). The 95% confidence intervals (1%-10%) were almost identical, indicating no difference between groups. The study was stopped after an interim analysis showed no significant difference in satisfaction between the groups. This could have been because the assumption that patients with increased risk of dissatisfaction do better with deeper sedation is incorrect. Another explanation could be the increased awareness of the value of benzodiazepines in endoscopy. Consistent with our findings, nervousness rather than pain predicted dissatisfaction, and the optimal use of anxiolytics with amnesic properties may be comparable to that of propofol.

RCT Entities:   Population Interventions Outcomes