Yichun Shuai, Yan Liu, Xiahong Yang, Qiaoqian Wan, Jie Zhao, Xin Wang
{"title":"谵妄风险与艾氯胺酮、七氟醚、异丙酚和右美托咪定相关:基于FDA不良事件报告系统的真实世界研究","authors":"Yichun Shuai, Yan Liu, Xiahong Yang, Qiaoqian Wan, Jie Zhao, Xin Wang","doi":"10.1016/j.ejphar.2025.177723","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><div>Delirium is a serious postoperative complication, increasingly recognized for its heightened risk following the use of sedative drugs. This study aimed to assess the relationship of esketamine, sevoflurane, propofol, and dexmedetomidine with the risk of delirium.</div></div><div><h3>Methods</h3><div>Data were obtained from the FDA Adverse Event Reporting System (FAERS) database covering the period from the first quarter of 2004 to the second quarter of 2024. Cases of delirium associated with these medications were identified using preferred terms (PTs) defined by the Medical Dictionary for Regulatory Activities (MedDRA 20.0). Disproportionality analyses employed reported odds ratios (ROR) and multiple gamma-Poisson shrinkage (MGPS), while logistic regression assessed the effects of age and sex on the risk of delirium.</div></div><div><h3>Results</h3><div>A total of 21,433,114 adverse events (AEs) were recorded in the FAERS database, including 16 cases of delirium associated with esketamine, 189 with propofol, 90 with sevoflurane, and 103 with dexmedetomidine. Propofol (ROR: 5.44, EBGM05: 4.8), sevoflurane (ROR: 9.9, EBGM05: 8.26), and dexmedetomidine (ROR: 21.1, EBGM05: 17.67) were significantly associated with the delirium risk, whereas esketamine (ROR: 1.45, EBGM05: 0.96) did not show a significant association. Age was identified as a significant risk factor for delirium, particularly in patients aged 55 years and older.</div></div><div><h3>Conclusion</h3><div>The findings indicate a significant correlation between propofol, sevoflurane, and dexmedetomidine and the risk of delirium, whereas esketamine does not appear to have a significant association with delirium. Future studies should further explore drug administration and dosage effects on delirium risk to improve clinical safety.</div></div>","PeriodicalId":12004,"journal":{"name":"European journal of pharmacology","volume":"1000 ","pages":"Article 177723"},"PeriodicalIF":4.2000,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Delirium risk associated with esketamine, sevoflurane, propofol, and dexmedetomidine: A real-world study based on the FDA adverse event reporting system\",\"authors\":\"Yichun Shuai, Yan Liu, Xiahong Yang, Qiaoqian Wan, Jie Zhao, Xin Wang\",\"doi\":\"10.1016/j.ejphar.2025.177723\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><div>Delirium is a serious postoperative complication, increasingly recognized for its heightened risk following the use of sedative drugs. This study aimed to assess the relationship of esketamine, sevoflurane, propofol, and dexmedetomidine with the risk of delirium.</div></div><div><h3>Methods</h3><div>Data were obtained from the FDA Adverse Event Reporting System (FAERS) database covering the period from the first quarter of 2004 to the second quarter of 2024. Cases of delirium associated with these medications were identified using preferred terms (PTs) defined by the Medical Dictionary for Regulatory Activities (MedDRA 20.0). Disproportionality analyses employed reported odds ratios (ROR) and multiple gamma-Poisson shrinkage (MGPS), while logistic regression assessed the effects of age and sex on the risk of delirium.</div></div><div><h3>Results</h3><div>A total of 21,433,114 adverse events (AEs) were recorded in the FAERS database, including 16 cases of delirium associated with esketamine, 189 with propofol, 90 with sevoflurane, and 103 with dexmedetomidine. Propofol (ROR: 5.44, EBGM05: 4.8), sevoflurane (ROR: 9.9, EBGM05: 8.26), and dexmedetomidine (ROR: 21.1, EBGM05: 17.67) were significantly associated with the delirium risk, whereas esketamine (ROR: 1.45, EBGM05: 0.96) did not show a significant association. Age was identified as a significant risk factor for delirium, particularly in patients aged 55 years and older.</div></div><div><h3>Conclusion</h3><div>The findings indicate a significant correlation between propofol, sevoflurane, and dexmedetomidine and the risk of delirium, whereas esketamine does not appear to have a significant association with delirium. Future studies should further explore drug administration and dosage effects on delirium risk to improve clinical safety.</div></div>\",\"PeriodicalId\":12004,\"journal\":{\"name\":\"European journal of pharmacology\",\"volume\":\"1000 \",\"pages\":\"Article 177723\"},\"PeriodicalIF\":4.2000,\"publicationDate\":\"2025-05-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European journal of pharmacology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0014299925004777\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European journal of pharmacology","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0014299925004777","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Delirium risk associated with esketamine, sevoflurane, propofol, and dexmedetomidine: A real-world study based on the FDA adverse event reporting system
Objective
Delirium is a serious postoperative complication, increasingly recognized for its heightened risk following the use of sedative drugs. This study aimed to assess the relationship of esketamine, sevoflurane, propofol, and dexmedetomidine with the risk of delirium.
Methods
Data were obtained from the FDA Adverse Event Reporting System (FAERS) database covering the period from the first quarter of 2004 to the second quarter of 2024. Cases of delirium associated with these medications were identified using preferred terms (PTs) defined by the Medical Dictionary for Regulatory Activities (MedDRA 20.0). Disproportionality analyses employed reported odds ratios (ROR) and multiple gamma-Poisson shrinkage (MGPS), while logistic regression assessed the effects of age and sex on the risk of delirium.
Results
A total of 21,433,114 adverse events (AEs) were recorded in the FAERS database, including 16 cases of delirium associated with esketamine, 189 with propofol, 90 with sevoflurane, and 103 with dexmedetomidine. Propofol (ROR: 5.44, EBGM05: 4.8), sevoflurane (ROR: 9.9, EBGM05: 8.26), and dexmedetomidine (ROR: 21.1, EBGM05: 17.67) were significantly associated with the delirium risk, whereas esketamine (ROR: 1.45, EBGM05: 0.96) did not show a significant association. Age was identified as a significant risk factor for delirium, particularly in patients aged 55 years and older.
Conclusion
The findings indicate a significant correlation between propofol, sevoflurane, and dexmedetomidine and the risk of delirium, whereas esketamine does not appear to have a significant association with delirium. Future studies should further explore drug administration and dosage effects on delirium risk to improve clinical safety.
期刊介绍:
The European Journal of Pharmacology publishes research papers covering all aspects of experimental pharmacology with focus on the mechanism of action of structurally identified compounds affecting biological systems.
The scope includes:
Behavioural pharmacology
Neuropharmacology and analgesia
Cardiovascular pharmacology
Pulmonary, gastrointestinal and urogenital pharmacology
Endocrine pharmacology
Immunopharmacology and inflammation
Molecular and cellular pharmacology
Regenerative pharmacology
Biologicals and biotherapeutics
Translational pharmacology
Nutriceutical pharmacology.