Abstract
Purpose :
To determine if oral sedation is non-inferior to intravenous (IV) sedation in patients undergoing surgery with a pars plana vitrectomy (PPV) in a tertiary care academic teaching hospital under monitored anesthesia care.
Methods :
A single center, randomized, double-masked, parallel-group study was conducted at Boston Medical Center. Patients were randomized (1:1) into one of two study arms: oral triazolam with IV placebo or oral placebo with IV midazolam. All patients received a regional block. The patients, anesthesiologists, surgeons, nurses and other operating room (OR) staff were blinded to treatment assignments. Patients were given the oral agent 30 minutes pre-operatively and the IV agent immediately prior to entering the OR. The primary outcome measure was patient satisfaction. Patients, surgeons, and anesthesia providers completed satisfaction surveys. The data was un-blinded and analyzed by a biostatistician.
Results :
Eighty-eight eyes of 88 subjects were randomized and 84 eyes completed full data analysis. An equal number of subjects (42) received oral and IV sedation. Mean patient satisfaction score in the oral group was 5.22 (scale 1-6) compared to 5.25 for the IV group (a priori non-inferiority margin of 0.5). The results demonstrate non-inferiority of oral sedation with a p-value of 0.002. Mean surgeon satisfaction was 5.43 in the oral group and 5.69 in the IV group (p=0.093) and mean anesthesiologist satisfaction was 5.02 in the oral group and 5.25 in the IV group (p=0.096), indicating no statistically significant difference between the 2 groups. No major intraoperative complications or serious perioperative adverse events occurred in either group. Minor intraoperative complications occurred at 4.8% in the oral group and 14.3% in the IV group (p=0.14). Minor perioperative adverse events were 16.7% in the oral group and 21.4% the IV group (p=0.58).
Conclusions :
This study found patient satisfaction for oral sedation is non-inferior to IV sedation when undergoing vitrectomy, indicating that oral sedation may be an alternative to standard IV sedation. The use of oral sedation may obviate the need for IV lines and fasting prior to surgery, further improving patient satisfaction. While this study was not powered for safety, the results may allow hospitals to transition vitrectomies in a select group of patients to a procedure room with in-room or on-site anesthesia support.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.