Abstract
Purpose :
Increasing interest in oral sedation has led many ophthalmologists to move toward this method for certain procedures, most notably cataract surgeries. However, it is still uncertain which ocular procedures are the best candidates for oral sedation. This prospective, randomized, double-masked clinical trial investigated whether oral sedation was non-inferior to intravenous (IV) sedation for conjunctival and corneal surgeries.
Methods :
Patients 18 years and older who were scheduled for DSEK, DMEK, conjunctival lesion excision, or pterygium surgery and were cleared to receive a benzodiazepine were randomized to either oral or IV sedation. The primary outcome assessed non-inferiority of patient satisfaction as determined by a 6 point, 12 question satisfaction survey, which was administered at the first post-operative appointment. Non-inferiority was determined through a t-test with an absolute non-inferiority margin of 0.5. Secondary outcomes included surgeon satisfaction, anesthesiologist satisfaction, additional anesthesia intervention, and surgical complication rates.
Results :
A total of 70 patients were randomized with 33 receiving oral sedation and 37 receiving IV sedation. On the satisfaction survey, the average score for patients randomized to oral sedation was 5.44±0.27 (range, 2.58-6.00) in comparison to 5.30±0.21 (range, 3.42-6.00) for IV sedation. Oral sedation was determined to be non-inferior to IV sedation with a probability of p = 0.0001. The data showed no significant difference in these results based on demographic factors, including sex, age, race, language, or ethnicity. There were no statistically significant differences between treatment groups with regard to operative times (p = 0.75), surgical complications (p = 0.33), or post-operative adverse events (p = 0.12).
Conclusions :
We report the non-inferiority of oral sedation in comparison to IV sedation based on patient satisfaction for conjunctival and corneal surgeries. These results indicate that oral sedation may be appropriate in anterior segment cases beyond cataract surgeries.
This is a 2020 ARVO Annual Meeting abstract.