Sedation versus no sedation in the performance of diagnostic upper gastrointestinal endoscopy:: A Canadian randomized controlled cost-outcome study

BACKGROUND: Sedation is not required to perform a technically adequate gastroscopy (EGDE), but does improve patient satisfaction, comfort, and willingness to repeat particularly in the elderly and those with decreased pharyngeal sensitivity. The comparative cost-efficacy of sedation versus no sedation remains poorly characterized. AIM: To compare the cost-efficacy of diagnostic EGDE with and without sedation in an adult ambulatory Canadian population. METHODS: A double-blind randomized controlled trial assigned patients to sedation versus placebo. "Successful endoscopy" was considered an EGDE rated 4/4 in technical adequacy (1 = inadequate to 4 = totally adequate), and 1-2/5 in patient self-reported comfort (1 = acceptable to 5 = unacceptable). Secondary outcomes included recovery room time, patient satisfaction alone, and willingness to repeat the procedure. Cost data were obtained using a published, institutional activity-based costing methodology. Analysis was intention to treat using standard univariate and multivariate methods. RESULTS: 419 patients (mean age 54.5, 48% male) were randomized (N = 210 active vs N = 209 placebo). Among patients randomized to active medication 76% of procedures were "successful" (placebo 46%), 79% were satisfied with their level of comfort (placebo 47%), and willingness to repeat was 81% (placebo 65%). We observed a 10% crossover rate from placebo to active medications. The use of sedation was the major determinant of successful endoscopy (OR = 3.8; 95% Cl: 2.5-5.7), but contributed to an increased recovery room time (29 vs 15 min; p < 0.0001). The expected cost of an additional successful endoscopy using sedation was $90.06 (CDN). In a planned subgroup analysis, among the elderly (>75; N = 53) unsedated endoscopy became the dominant approach. Indeed, in this population, a trend was observed favoring the effectiveness of placebo (63%) versus active medication (57%) (OR = 0.75; 95% Cl: 0.25-2.3) and was less costly resulting in $450 savings/unsedated EGDE. CONCLUSIONS: In the average Canadian ambulatory adult population, sedated diagnostic EGDE is more costly but remains an efficacious strategy by increasing the rate of successful endoscopies, patient satisfaction, and willingness to repeat. However, among the elderly (>75 yr), an unsedated strategy may be more cost-efficacious.