比较苯二氮卓-氯胺酮与苯二氮卓-芬太尼镇静在超声乳化术中的作用:一项双盲交叉非劣效性临床试验(BEKEF)

IF 3.4
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引用次数: 0

摘要

背景:白内障手术的表面麻醉通常需要辅助镇静来控制术中不适和提高患者的配合。氯胺酮和芬太尼与苯二氮卓类药物联合使用是常用的镇静方案,但它们在白内障手术中的相对安全性和有效性仍未得到充分研究。本研究旨在评价氯胺酮联合咪达唑仑在超声乳化术中的镇静作用是否不劣于芬太尼联合咪达唑仑,其非劣效裕度为10%。方法本前瞻性、双盲、交叉、非劣效性试验随机选取75例患者接受两种镇静方案的双侧超声乳化术。两次手术之间有15天的洗脱期。充分镇静的定义为拉姆齐镇静量表评分2-3分。主要结局是镇静充足性,次要结局包括患者和外科医生满意度、手术指标和并发症。结果在75名随机患者中,65名(130只眼睛)完成了研究。86.2%的氯胺酮组和89.2%的芬太尼组达到了足够的镇静效果,参与者内差异为3.1% (95% CI: - 2.3%-5.3%),证实了非劣效性。两组患者满意度得分相似(氯胺酮:4.87±0.36;芬太尼:4.91±0.28;P = 0.45)。并发症很少,芬太尼组有2例恶心和2例心动过缓,氯胺酮组有1例恶心和2例高血压。结论氯胺酮联合咪达唑仑是芬太尼类白内障手术中安全有效的镇静替代方案,镇静质量和满意度相当。这些发现支持氯胺酮在白内障手术中的应用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparing benzodiazepine-ketamine and benzodiazepine-fentanyl sedation in phacoemulsification: A double-blind crossover non-inferiority clinical trial (BEKEF study)

Background

Topical anesthesia for cataract surgery often requires adjunctive sedation to manage intraoperative discomfort and improve patient cooperation. Ketamine and fentanyl, combined with benzodiazepines, are commonly used sedation regimens, but their comparative safety and efficacy in the cataract surgery context remain underexplored. This study aimed to evaluate whether ketamine combined with midazolam is non-inferior to fentanyl combined with midazolam for sedation during phacoemulsification, with a non-inferiority margin of 10%.

Methods

This prospective, double-blind, crossover, non-inferiority trial randomized 75 patients to receive both sedation regimens for bilateral phacoemulsification. A 15-day washout period was implemented between surgeries. Adequate sedation was defined as a Ramsay Sedation Scale score of 2–3. The primary outcome was sedation adequacy, with secondary outcomes including patient and surgeon satisfaction, surgical metrics, and complications.

Results

Of the 75 randomized patients, 65 (130 eyes) completed the study. Adequate sedation was achieved in 86.2% of cases with ketamine and 89.2% with fentanyl, with a within-participant difference of 3.1% (95% CI: −2.3%–5.3%), confirming non-inferiority. Patient satisfaction scores were similarly high between regimens (ketamine: 4.87 ​± ​0.36; fentanyl: 4.91 ​± ​0.28; P ​= ​0.45). Complications were infrequent, with two cases of nausea and two of bradycardia in the fentanyl group and one case of nausea and two of hypertension in the ketamine group.

Conclusions

Ketamine combined with midazolam is a safe and effective alternative to fentanyl-based sedation for cataract surgery, providing comparable sedation quality and satisfaction. These findings support ketamine's use in cataract surgery.
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CiteScore
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