Patient Satisfaction With Oral vs Intravenous Sedation for Vitrectomy Surgery: A Randomized, Noninferiority Clinical Trial

Abstract

Purpose: This work aims to determine whether patient satisfaction with oral sedation is noninferior to intravenous (IV) sedation in vitrectomy surgery. Methods: This prospective, randomized, double-masked, noninferiority clinical trial measured patient satisfaction in 84 participants receiving oral or IV sedation during vitrectomy surgery under monitored anesthesia care. Patients were excluded if they were unable to receive benzodiazepines. Results: The primary outcome was patient satisfaction. Secondary outcomes included surgeon and anesthesia provider satisfaction, need for supplemental anesthesia, and surgical complications. Among the 84 patients (46 [54.8%] men; mean [SD] age, 57.0 [12.7 years]), mean patient satisfaction scores were 5.22 ± 0.81 (range, 3.08-6; scale 1-6) with oral and 5.25 ± 0.63 (range, 3.83-6; scale 1-6) with IV sedation. With an a priori noninferiority margin of 0.5 and a difference in mean scores between the groups of 0.03 (1-tailed 95% CI, infinity to 0.29), our results demonstrated the noninferiority of oral sedation ( P = .002). There were no significant differences in surgeon or anesthesia satisfaction or major intraoperative complications. Five patients receiving oral (11.9%) and 3 receiving IV (7.1%) sedation required supplemental IV sedation (difference, 4.8%; P = .46). Conclusions: Patient satisfaction for oral sedation was noninferior to IV sedation for vitrectomy surgery.

Long-Term Satisfaction of Oral Sedation versus Standard-of-Care Intravenous Sedation for Ocular Surgery

“…Our group conducted the oral versus intravenous sedation (OIV) study at Boston Medical Center, in which we randomized nearly 300 patients undergoing anterior segment, vitreoretinal, and glaucoma surgeries to either oral or intravenous (IV) sedation and investigated patient satisfaction during the post-operative period. Our published results in Peeler et al (2019), Siegel et al (2022), and Lee et al (2022) established noninferiority of oral sedation to IV sedation in cataract, retina, and non-cataract anterior segment surgeries, respectively. [16][17][18] The safety of oral sedation in cataract surgery has been well established.…”

Diverse Research Teams and Underrepresented Groups in Clinical Studies

“…A total of 10 prospective studies involving 1380 total patients who were approached for consent met inclusion criteria; 3 cohort studies have not been published (J.R.T., recruitment closed, ongoing data analysis May 2023; T.P., ongoing recruitment, September 2023; and A.G.D., recruitment suspended temporarily due to change in principal investigator, September 2023). Table 1 describes the included studies.…”

“…A total of 10 prospective studies [14][15][16][17][18][19][20][21][22][23][24] 1). Patient age, preferred language, and whether or not the patient was approached for consent at their initial visit were not associated with the decision to consent (Table 2).…”

“…A total of 10 prospective studies [14][15][16][17][18][19][20][21][22][23][24] involving 1380 total patients who were approached for consent met inclusion criteria; 3 cohort studies have not been published (J.R.…”

“…Most studies offered reimbursement for time and travel, and therefore, this was not considered in our analysis (Table 1). In addition, the majority of the study population came from a single large clinical trial (Oral Vs Intra-venous Sedation for Ocular Procedures trial [14][15][16][17] ), but when the analysis was repeated with only the trial's study participants, the outcomes were similar. Furthermore, the representation of SES in our model is limited by several factors, including binary categorization of the ADI score as low or high (although the mean ADI in the study population was in alignment with the cutoff used) and restrictions inherent in the US Census Bureau database, such as incomplete accounting for undocumented immigrant populations.…”