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. 2021 Aug 3;6(3):201-209.
doi: 10.1177/24741264211027820. eCollection 2022 May-Jun.

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

Nicole H Siegel  1 , Marissa G Fiorello  1 , Steven Ness  1 , Jiwoo Kim  1 , Viha Vig  1 , Crandall E Peeler  1   2 , Xuejing Chen  1 , Manju L Subramanian  1 ; Oral vs IV Sedation (ORVIS) Study Group
Affiliations

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

Nicole H Siegel et al. J Vitreoretin Dis. .

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.

Keywords: clinical trial; intravenous sedation; noninferiority; oral sedation; patient satisfaction; vitrectomy surgery.

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Conflict of interest statement

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
Consolidated Standards of Reporting Trials flowchart. IV indicates intravenous.
See this image and copyright information in PMC

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