Patient Satisfaction with Oral Versus Intravenous Sedation for Cataract Surgery : A Randomized Clinical Trial

Abstract Purpose To determine whether patient satisfaction with oral sedation is non-inferior to intravenous (IV) sedation for cataract surgery. Design A prospective, randomized, double-masked clinical trial. Subjects A volunteer sample of patients age 18 or older from diverse ethnic, racial, and socioeconomic backgrounds scheduled for cataract surgery. Patients were excluded if they were allergic to benzodiazepines, over the age of 70 and failed a delirium screening questionnaire, pregnant or nursing, using a medication inhibiting cytochrome 450 3A, or intoxicated on the day of surgery. Intervention Patients were randomized to receive either oral triazolam with IV placebo or IV midazolam with oral placebo preoperatively. Main Outcomes Measures The primary outcome was patient satisfaction, measured by a survey administered on postoperative day 1. Secondary outcomes included surgeon and anesthesia provider satisfaction, need for supplemental anesthesia, and surgical complications. Results Among the 85 patients (42 [49.4%] men; mean [SD] age, 65.8 [9.5]) completing the study, the mean patient satisfaction score was 5.34 ± 0.63 (range 3.75 to 6) in the oral sedation group and 5.40 ± 0.52 (range 4 to 6) in the IV group. With an a priori non-inferiority margin of 0.5 and a difference in mean scores between the two groups of 0.06 (one-tailed, 95% CI, –infinity to 0.27), our results demonstrate non-inferiority of oral sedation with a p-value of 0.0004. Surgeon and anesthesia provider satisfaction was similar between the two groups. Intraoperative complications occurred in 16.7% in the oral group and 9.3% in the IV group (difference 7.4%; 95% CI, -6.9% to 21.6%; p=0.31). The only major intraoperative complication – a posterior capsular tear – occurred in the IV group. Eight patients in the oral group (19.0%) and 3 in the IV group (7.0%) received supplemental IV sedation (difference 12.1%; 95% CI, -2.0% to 26.2%; p=0.097). Conclusion The use of oral sedation in cataract surgery has been suggested as a cost- and space-saving measure, potentially allowing the transition of some cases from an operating to procedure room or office-based setting. We report the non-inferiority of oral compared with IV sedation for cataract surgery in a diverse patient population in terms of patient satisfaction.