Patient Satisfaction for Oral versus Intravenous Sedation for Glaucoma Procedures

Abstract

Purpose : Establishing non-inferiority in patient satisfaction between oral and intravenous (IV) sedation in glaucoma surgery could allow for use of oral sedation in these procedures. This randomized, double-blind, parallel-group study evaluated post-operative patient satisfaction in patients from a diverse background.

Methods : Forty-four subjects 18 years of age or older undergoing glaucoma procedures of drainage implant (Ahmed or Baerveldt valve), Trabeculectomy, Baerveldt, Endocyclophotocoagulation (ECP), iStent microstent, Kahook Dual Blade goniotomy, or Cypass microstent (including combination with phacoemulsification and intraocular lens implant) were enrolled. Each subject was randomized (1:1) into one of two study groups; oral triazolam with IV placebo or IV midazolam with oral placebo. The primary outcome measure was patient satisfaction which was surveyed one day post procedure. Secondary outcome measures were surgeon and anesthesiologist satisfaction, which were assessed immediately post procedure. Non-inferiority of sedation was determined within a satisfaction score of 5.5, and a non-inferiority margin of 0.5. Surgeon and anesthesiologist satisfaction scores, additional anesthesia intervention and related complications were independently analyzed.

Results : Among the 44 subjects enrolled (24 men [54.5%], 20 women [45.5%], mean age of 66.52±11.32 years old), the mean satisfaction score for the oral group (n=25) was 5.10±0.90 (range 3-6) and the score for the IV group (n=19) was 5.00±0.86 (range 3.5-6). Oral sedation was found to be non-inferior to IV sedation (p=0.02). There were no statistically significant differences between the two groups in terms of mean surgeon satisfaction (p=0.57) and mean anesthesiologist satisfaction (p=0.10). Sixteen participants received additional intraoperative anesthesia, although there was no statistical significance between the two groups (p=0.50). Between the two groups, there was also no difference between intraoperative complication rate (p=0.60) or incidence of adverse events (p=0.42).

Conclusions : This is the first study to investigate a comparison in oral versus IV sedation for glaucoma procedures. Oral sedation was identified to be non-inferior to IV sedation when comparing satisfaction scores from a diverse patient population.

This is a 2020 ARVO Annual Meeting abstract.