Department of Ophthalmology, Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts; Department of Neurology, Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts.
Department of Ophthalmology, Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts.
Ophthalmology. 2019 Sep;126(9):1212-1218. doi: 10.1016/j.ophtha.2019.04.022. Epub 2019 Apr 16.
To determine whether patient satisfaction with oral sedation is noninferior to intravenous sedation for cataract surgery.
Prospective, randomized, double-masked clinical trial.
A volunteer sample of patients 18 years or older from diverse backgrounds scheduled for cataract surgery. Patients who were allergic to benzodiazepines, older than 70 years with a failed delirium screening questionnaire, pregnant or nursing, using a medication inhibiting cytochrome 450 3A, or intoxicated on the day of surgery were excluded.
Patients were randomized to receive either oral triazolam with intravenous placebo or intravenous midazolam with oral placebo before surgery.
The primary outcome was patient satisfaction, measured by a survey administered on postoperative day 1. Secondary outcomes included surgeon and anesthesia provider satisfaction, need for supplemental anesthesia, and surgical complications.
Among the 85 patients (42 men [49.4%]; mean age, 65.8 years; standard deviation, 9.5 years) completing the study, the mean satisfaction score was 5.34±0.63 (range, 3.75-6) in the oral sedation group and 5.40±0.52 (range, 4-6) in the intravenous group. With an a priori noninferiority margin of 0.5 and a difference in mean scores between the 2 groups of 0.06 (1-tailed 95% confidence interval [CI], -infinity to 0.27), our results demonstrate noninferiority of oral sedation with a P value of 0.0004. Surgeon and anesthesia provider satisfaction was similar between the 2 groups. Intraoperative complications occurred in 16.7% in the oral group and 9.3% in the intravenous group (difference, 7.4%; 95% CI, -6.9% to 21.6%; P = 0.31). The only major intraoperative complication-a posterior capsular tear-occurred in the intravenous group. Eight patients in the oral group (19.0%) and 3 in the intravenous group (7.0%) received supplemental intravenous sedation (difference, 12.1%; 95% CI, -2.0% to 26.2%; P = 0.097).
The use of oral sedation in cataract surgery has been suggested as a cost- and space-saving measure, potentially allowing the transition of some patients from an operating to procedure room or office-based setting. We report the noninferiority of oral compared with intravenous sedation for cataract surgery in a diverse patient population in terms of patient satisfaction.
确定白内障手术中患者对口服镇静的满意度是否不低于静脉镇静。
前瞻性、随机、双盲临床试验。
来自不同背景的 18 岁及以上志愿者样本，计划接受白内障手术。对苯二氮䓬类药物过敏、70 岁以上且有谵妄筛查问卷失败、怀孕或哺乳、使用抑制细胞色素 450 3A 的药物或手术当天中毒的患者被排除在外。
患者在手术前随机接受口服三唑仑和静脉安慰剂或静脉咪达唑仑和口服安慰剂。
主要结局是术后第 1 天通过问卷调查评估的患者满意度。次要结局包括外科医生和麻醉提供者的满意度、需要补充麻醉以及手术并发症。
在 85 名完成研究的患者（42 名男性[49.4%]；平均年龄 65.8 岁；标准差 9.5 岁）中，口服镇静组的平均满意度评分为 5.34±0.63（范围，3.75-6），静脉组为 5.40±0.52（范围，4-6）。根据预先设定的非劣效性边界为 0.5 和两组之间的平均评分差异为 0.06（单侧 95%置信区间[CI]，-无穷大至 0.27），我们的结果表明口服镇静具有非劣效性，P 值为 0.0004。两组间外科医生和麻醉提供者的满意度相似。口服组术中并发症发生率为 16.7%，静脉组为 9.3%（差异为 7.4%；95%CI，-6.9%至 21.6%；P=0.31）。唯一的主要术中并发症是后囊撕裂，发生在静脉组。口服组有 8 名患者（19.0%）和静脉组有 3 名患者（7.0%）需要补充静脉镇静（差异为 12.1%；95%CI，-2.0%至 26.2%；P=0.097）。
白内障手术中使用口服镇静已被认为是一种节省成本和空间的措施，可能使一些患者从手术室或办公室环境过渡到手术中。我们报告了在不同患者人群中，口服镇静与静脉镇静相比，在白内障手术中的非劣效性，表现在患者满意度方面。
