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

Purpose: To determine whether patient satisfaction with oral sedation is noninferior to intravenous sedation for cataract surgery. Design: Prospective, randomized, double-masked clinical trial. Participants: A volunteer sample of patients 18 years or older from diverse backgrounds scheduled for cataract surgery. Patients who were allergic to benzodiazepines, older than 70 years with a failed delirium screening questionnaire, pregnant or nursing, using a medication inhibiting cytochrome 450 3A, or intoxicated on the day of surgery were excluded. Methods: Patients were randomized to receive either oral triazolam with intravenous placebo or intravenous midazolam with oral placebo before surgery. 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 men [49.4%]; mean age, 65.8 years; standard deviation, 9.5 years) completing the study, the mean satisfaction score was 5.34 +/- 0.63 (range, 3.75-6) in the oral sedation group and 5.40 +/- 0.52 (range, 4-6) in the intravenous group. With an a priori noninferiority margin of 0.5 and a difference in mean scores between the 2 groups of 0.06 (1-tailed 95% confidence interval [CI], -infinity to 0.27), our results demonstrate noninferiority of oral sedation with a P value of 0.0004. Surgeon and anesthesia provider satisfaction was similar between the 2 groups. Intraoperative complications occurred in 16.7% in the oral group and 9.3% in the intravenous 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 intravenous group. Eight patients in the oral group (19.0%) and 3 in the intravenous group (7.0%) received supplemental intravenous sedation (difference, 12.1%; 95% CI, -2.0% to 26.2%; P = 0.097). Conclusions: The use of oral sedation in cataract surgery has been suggested as a cost- and space-saving measure, potentially allowing the transition of some patients from an operating to procedure room or office-based setting. We report the noninferiority of oral compared with intravenous sedation for cataract surgery in a diverse patient population in terms of patient satisfaction. (C) 2019 by the American Academy of Ophthalmology