Comparing Cognitive Recovery of Remimazolam versus Propofol in Elderly Patients Undergoing Colonoscopy: A Randomized Controlled Trial.

IF 3.5 3区 医学 Q2 GERIATRICS & GERONTOLOGY
Clinical Interventions in Aging Pub Date : 2024-12-16 eCollection Date: 2024-01-01 DOI:10.2147/CIA.S490330
Shuying Lin, Ying Wei, Yifen Zhuo, Shiqin Que, Xuepeng Jin, Yusheng Yao, Bin Qian
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引用次数: 0

Abstract

Background: Remimazolam, a novel ultra-short-acting benzodiazepine, shows promise for procedural sedation. This study compared the cognitive recovery of remimazolam versus propofol in elderly patients undergoing colonoscopy.

Patients and methods: In this prospective, randomized, double-blind, controlled trial, 228 patients aged ≥ 65 years undergoing outpatient colonoscopies were recruited. Patients received intravenous sufentanil 0.05 μg/kg, followed by either remimazolam 0.2 mg/kg or propofol 1 mg/kg for sedation induction. The assigned study drug (remimazolam 0.1 mg/kg or propofol 0.5 mg/kg) was titrated to maintain a Modified Observer's Assessment of Alertness/Sedation scale score < 3 during the procedure. The primary outcome was the incidence of cognitive recovery, assessed using the Postoperative Quality of Recovery Scale (PostopQRS) cognitive domain on postoperative day 3. Secondary outcomes included overall and other PostopQRS domains recovery, time to discharge, patient satisfaction, and adverse events.

Results: Cognitive recovery on day 3 was similar between remimazolam (84.2%) and propofol (85.1%) groups (risk ratio = 0.99; 95% CI: 0.89-1.11; p = 0.854). No significant differences were observed in overall recovery, other domains, or discharge time. Remimazolam patients reported higher satisfaction (p = 0.001) and experienced lower incidences of hypotension (21.9% vs 53.5%; p < 0.001), hypoxemia (6.1% vs 16.7%; p = 0.024), and injection site pain (15.8% vs 41.2%; p < 0.001) compared to propofol.

Conclusion: In elderly patients undergoing colonoscopy, remimazolam demonstrated comparable cognitive recovery to propofol, with higher patient satisfaction and a more favorable safety profile. Remimazolam may be the preferred alternative to propofol for procedural sedation in this vulnerable population.

Trial registration: The Chinese Clinical Trial Registry, ChiCTR2200066689.

比较老年结肠镜检查患者雷马唑仑与异丙酚的认知恢复:一项随机对照试验。
背景:雷马唑仑是一种新型超短效苯二氮卓类药物,有望用于程序性镇静。本研究比较了老年结肠镜检查患者雷马唑仑与异丙酚的认知恢复情况。患者和方法:在这项前瞻性、随机、双盲、对照试验中,招募了228例年龄≥65岁接受门诊结肠镜检查的患者。患者静脉滴注舒芬太尼0.05 μg/kg,随后雷马唑仑0.2 mg/kg或异丙酚1 mg/kg镇静诱导。在手术过程中,对指定的研究药物(雷马唑仑0.1 mg/kg或异丙酚0.5 mg/kg)进行滴定,以保持修改的观察者警觉/镇静量表评分< 3。主要终点是认知恢复的发生率,在术后第3天使用术后恢复质量量表(PostopQRS)认知域进行评估。次要结局包括总体和其他PostopQRS域的恢复、出院时间、患者满意度和不良事件。结果:雷马唑仑组与异丙酚组第3天认知恢复相似(风险比= 0.99;95% ci: 0.89-1.11;P = 0.854)。在总体恢复、其他领域或出院时间方面没有观察到显著差异。雷马唑仑患者满意度较高(p = 0.001),低血压发生率较低(21.9% vs 53.5%;P < 0.001),低氧血症(6.1% vs 16.7%;P = 0.024),注射部位疼痛(15.8% vs 41.2%;P < 0.001)。结论:在接受结肠镜检查的老年患者中,雷马唑仑表现出与异丙酚相当的认知恢复,患者满意度更高,安全性更佳。在这一脆弱人群中,雷马唑仑可能是异丙酚程序性镇静的首选替代品。试验注册:中国临床试验注册中心,ChiCTR2200066689。
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来源期刊
Clinical Interventions in Aging
Clinical Interventions in Aging GERIATRICS & GERONTOLOGY-
CiteScore
6.80
自引率
2.80%
发文量
193
审稿时长
6-12 weeks
期刊介绍: Clinical Interventions in Aging, is an online, peer reviewed, open access journal focusing on concise rapid reporting of original research and reviews in aging. Special attention will be given to papers reporting on actual or potential clinical applications leading to improved prevention or treatment of disease or a greater understanding of pathological processes that result from maladaptive changes in the body associated with aging. This journal is directed at a wide array of scientists, engineers, pharmacists, pharmacologists and clinical specialists wishing to maintain an up to date knowledge of this exciting and emerging field.
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