Lee Hyunjoo J, Desai Manishi A, Sadlak Natalie, Fiorello Marissa G, Githere Wanjiku G, Subramanian Manju L
Department of Ophthalmology, Boston Medical Center, Boston, MA, USA.
Clin Ophthalmol. 2022 Jul 1;16:2105-2117. doi: 10.2147/OPTH.S354570. eCollection 2022.
To determine whether oral sedation is as safe and effective as IV sedation for ophthalmic surgeries other than cataract surgery, we tested whether patient satisfaction with oral triazolam was non-inferior to IV midazolam for cornea and glaucoma surgeries.
Seventy-five cornea and 49 glaucoma surgery patients 18 years and older at Boston Medical Center (Boston, MA) were randomized within each study group (cornea or glaucoma) to receive oral triazolam + IV placebo, or oral placebo + IV midazolam before surgery in a double-masked fashion. Supplemental IV anesthesia was administered as needed during surgery. The primary outcome measure was patient satisfaction with anesthesia, compared between oral and IV sedation groups via -test for non-inferiority, based on 70 cornea and 43 glaucoma subjects completing the study. Secondary outcome measures included surgeon and anesthesia provider satisfaction with anesthesia, rate of supplemental IV anesthesia, and incidence of adverse events and surgical complications.
Using an a priori non-inferiority margin of 0.5, initial oral sedation was non-inferior to initial IV sedation in cornea (n=70, p<0.001) and glaucoma (n=43, p=0.017) groups, even after excluding subjects administered supplemental IV anesthesia. There were no significant differences in anesthesia provider or surgeon satisfaction, intra-operative complications, adverse events, or supplemental anesthesia between groups, except for higher anesthesia provider satisfaction with oral sedation in an Ahmed or Baerveldt implant ± cataract surgery sub-group (p=0.04). Subjects receiving supplemental anesthesia included 6 oral (18.2%) and 5 IV (13.5%) in the cornea group (p=0.59), and 7 oral (29.2%) and 6 IV (31.6%) in the glaucoma group (p=0.50).
Our results suggest that an initial dose of oral triazolam is equivalent to IV midazolam for non-cataract anterior segment surgeries. However, there was a relatively high need for supplemental IV anesthesia during some surgery types, particularly with glaucoma tube shunt implantation.
为了确定在白内障手术以外的眼科手术中，口服镇静是否与静脉注射镇静一样安全有效，我们测试了在角膜和青光眼手术中，患者对口服三唑仑的满意度是否不低于静脉注射咪达唑仑。
波士顿医疗中心（马萨诸塞州波士顿）的75名18岁及以上的角膜手术患者和49名青光眼手术患者，在每个研究组（角膜或青光眼）内随机分组，以双盲方式在手术前接受口服三唑仑+静脉注射安慰剂，或口服安慰剂+静脉注射咪达唑仑。手术期间根据需要给予补充静脉麻醉。主要结局指标是患者对麻醉的满意度，基于70名角膜手术患者和43名青光眼手术患者完成研究，通过非劣效性检验在口服和静脉镇静组之间进行比较。次要结局指标包括外科医生和麻醉提供者对麻醉的满意度、补充静脉麻醉的比例以及不良事件和手术并发症的发生率。
使用预先设定的非劣效性界值0.5，即使排除接受补充静脉麻醉的受试者，在角膜组（n = 70，p < 0.001）和青光眼组（n = 43，p = 0.017）中，初始口服镇静也不劣于初始静脉镇静。除了在接受艾哈迈德或贝尔维尔德特植入物±白内障手术的亚组中麻醉提供者对口服镇静的满意度更高（p = 0.04）外，两组之间在麻醉提供者或外科医生满意度、术中并发症、不良事件或补充麻醉方面没有显著差异。在角膜组中，接受补充麻醉的受试者包括6名口服（18.2%）和5名静脉注射（13.5%）（p = 0.59），在青光眼组中，接受补充麻醉的受试者包括7名口服（29.2%）和6名静脉注射（31.6%）（p = 0.50）。
我们的结果表明，对于非白内障前段手术，口服三唑仑的初始剂量等同于静脉注射咪达唑仑。然而，在某些手术类型中，特别是青光眼引流管植入手术，对补充静脉麻醉的需求相对较高。
