瑞马唑仑与丙泊酚用于老年结肠镜检查患者认知恢复的比较：一项随机对照试验
Comparing Cognitive Recovery of Remimazolam versus Propofol in Elderly Patients Undergoing Colonoscopy: A Randomized Controlled Trial.
作者信息
Lin Shuying, Wei Ying, Zhuo Yifen, Que Shiqin, Jin Xuepeng, Yao Yusheng, Qian Bin
机构信息
Department of Anesthesiology, People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine, Fuzhou, People's Republic of China.
Department of Anesthesiology, Fujian Maternity and Child Health Hospital, College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical University, Fuzhou, People's Republic of China.
出版信息
Clin Interv Aging. 2024 Dec 16;19:2133-2143. doi: 10.2147/CIA.S490330. eCollection 2024.
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.
背景
瑞马唑仑是一种新型超短效苯二氮䓬类药物，在程序镇静方面显示出前景。本研究比较了瑞马唑仑与丙泊酚在老年结肠镜检查患者中的认知恢复情况。
患者与方法
在这项前瞻性、随机、双盲、对照试验中，招募了228名年龄≥65岁的门诊结肠镜检查患者。患者静脉注射舒芬太尼0.05μg/kg，随后分别给予瑞马唑仑0.2mg/kg或丙泊酚1mg/kg进行镇静诱导。在操作过程中，滴定给予指定的研究药物（瑞马唑仑0.1mg/kg或丙泊酚0.5mg/kg）以维持改良的观察者警觉/镇静评估量表评分<3。主要结局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）认知领域进行评估。次要结局包括总体和其他PostopQRS领域恢复情况、出院时间、患者满意度和不良事件。
结果
瑞马唑仑组（84.2%）和丙泊酚组（85.1%）在术后第3天的认知恢复情况相似（风险比=0.99；95%置信区间：0.89-1.11；p=0.854）。在总体恢复、其他领域或出院时间方面未观察到显著差异。与丙泊酚相比，瑞马唑仑组患者报告更高的满意度（p=0.001），且低血压（21.9%对53.5%；p<0.001）、低氧血症（6.1%对16.7%；p=0.024）和注射部位疼痛（15.8%对41.2%；p<0.001）的发生率更低。
结论
在接受结肠镜检查的老年患者中，瑞马唑仑的认知恢复情况与丙泊酚相当，患者满意度更高，安全性更优。在这一脆弱人群中，瑞马唑仑可能是丙泊酚用于程序镇静的首选替代药物。
试验注册
中国临床试验注册中心，ChiCTR2200066689。
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