Siegel Nicole H, Fiorello Marissa G, Ness Steven, Kim Jiwoo, Vig Viha, Peeler Crandall E, Chen Xuejing, Subramanian Manju L
Department of Ophthalmology, Boston Medical Center, Boston University School of Medicine, Boston, MA, USA.
Department of Neurology, Boston Medical Center, Boston University School of Medicine, Boston, MA, USA.
J Vitreoretin Dis. 2021 Aug 3;6(3):201-209. doi: 10.1177/24741264211027820. eCollection 2022 May-Jun.
This work aims to determine whether patient satisfaction with oral sedation is noninferior to intravenous (IV) sedation in vitrectomy surgery.
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.
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 ( = .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%; = .46).
Patient satisfaction for oral sedation was noninferior to IV sedation for vitrectomy surgery.
本研究旨在确定玻璃体切除手术中患者对口服镇静的满意度是否不低于静脉镇静。
这项前瞻性、随机、双盲、非劣效性临床试验测量了84名在麻醉监护下接受玻璃体切除手术时接受口服或静脉镇静的参与者的患者满意度。如果患者无法接受苯二氮䓬类药物，则将其排除。
主要结局是患者满意度。次要结局包括外科医生和麻醉提供者的满意度、补充麻醉的需求以及手术并发症。在这84名患者中（46名[54.8%]男性；平均[标准差]年龄为57.0[12.7岁]），口服镇静组的平均患者满意度评分为5.22±0.81（范围为3.08 - 6；评分标准为1 - 6），静脉镇静组为5.25±0.63（范围为3.83 - 6；评分标准为1 - 6）。预先设定的非劣效性界值为0.5，两组平均评分差异为0.03（单尾95%置信区间，负无穷到0.29），我们的结果证明了口服镇静的非劣效性（P = 0.002）。外科医生或麻醉满意度或主要术中并发症方面无显著差异。5名接受口服镇静的患者（11.9%）和3名接受静脉镇静的患者（7.1%）需要补充静脉镇静（差异为4.8%；P = 0.46）。
玻璃体切除手术中患者对口服镇静的满意度不低于静脉镇静。
