Oral noninferior to intravenous sedation for cataract surgery
Oral sedation is noninferior to intravenous sedation for cataract surgery in terms of patient satisfaction in a diverse patient population, a study has shown.
“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,” the authors said.
A total of 85 patients (mean age, 65.7 years; 49.4 percent men; standard deviation, 9.5 years) were included. 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.
Noninferiority of oral sedation was shown by an a priori noninferiority margin of 0.5 and a difference in mean scores between the two groups of 0.06 (1-tailed 95 percent CI, –infinity to 0.27; p=0.0004). The two groups also had similar surgeon and anaesthesia provider satisfaction.
Intraoperative complications occurred in 16.7 percent and 9.3 percent in the oral and intravenous groups (difference, 7.4, –6.9 to 21.6 percent; p=0.31), respectively. The only major intraoperative complication, a posterior capsular tear, occurred in the intravenous group.
Supplemental intravenous sedation was given to eight patients (19.0 percent) in the oral group and three (7.0 percent) in the intravenous group (difference, 12.1 percent, –2.0 to 26.2 percent; p=0.097).
This prospective, randomized, double-masked clinical trial included a volunteer sample of patients aged ≥18 years from diverse backgrounds scheduled for cataract surgery. Excluded were those who were allergic to benzodiazepines, aged >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.
Patients were randomly assigned to receive either oral triazolam with intravenous placebo or intravenous midazolam with oral placebo before surgery. Patient satisfaction, measured by a survey administered on postoperative day 1, was the primary outcome. Secondary outcomes included surgeon and anaesthesia provider satisfaction, need for supplemental anaesthesia, and surgical complications.