{"title":"雷马唑仑联合瑞芬太尼减轻老年女性患者喉罩气道插入过程中的应激反应的剂量-反应研究:一项前瞻性双盲研究。","authors":"Qiang Xu, Jing Qian, Su-Qin Zhang, Feng Xia, Hui-Jing Hu, Fei Xiao","doi":"10.2147/DDDT.S494426","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Optimum dose of remimazolam for inducing loss of consciousness in elderly patients has been suggested by prior studies. Opioids can enhance their sedative effects, thereby permitting dose reduction. However, the dose-response of remimazolam when combined remifentanil for attenuating stress response during laryngeal mask airway (LMA) insertion in elderly female patients is still unknown. Moreover, the ideal dose of medications is especially critical in elderly patients due to their compromised cardiopulmonary function. The objective of this study was to determine the median effective dose (ED50) and ED95 of remimazolam in inhibiting the stress response associated with LMA insertion.</p><p><strong>Methods: </strong>Sixty aged ≥ 65 and < 80 years old female patients were randomized allocated into 1 of 4 groups receiving doses of 0.2, 0.25, 0.3, and 0.35 mg/kg remimazolam. Following a dosage of 2.0 ng/mL of remifentanil, patients received different doses of remimazolam. Effective dose is defined as the prevention of stress response associated with LMA insertion, characterized by a post-sedation induction SBP variation < 20% of baseline value, jaw relaxation and absence of patient body motion during the initial 2 minutes following LMA insertion. Probit regression analysis was utilized to estimate the ED50 and ED90 values.</p><p><strong>Results: </strong>The ED50 and ED95 of effective remimazolam of general induction for elderly female patients not suffer intubation stress response were 0.24 mg/kg (95% CI 0.20-0.27 mg/kg) and 0.37 mg/kg (95% CI 0.32-0.49 mg/kg), respectively. The incidence of hypotension was 33.3% (5/15), 46.7% (7/15), 73.3% (11/15), and 80% (12/15) in the four groups, respectively.</p><p><strong>Conclusion: </strong>The ED50 and ED95 values of intravenous remimazolam for preventing stress response during LMA insertion were 0.24 and 0.37 mg/kg, respectively in elderly female.</p><p><strong>Trial number and registry url: </strong>Registration number, ChiCTR2400083990, https://www.chictr.org.cn/showproj.html?proj=229006.</p>","PeriodicalId":11290,"journal":{"name":"Drug Design, Development and Therapy","volume":"19 ","pages":"1575-1583"},"PeriodicalIF":5.1000,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11891449/pdf/","citationCount":"0","resultStr":"{\"title\":\"Dose-Response Study of Remimazolam Combined With Remifentanil for Attenuating Stress Response During Laryngeal Mask Airway Insertion in Elderly Female Patients: A Prospective Double-Blinded Study.\",\"authors\":\"Qiang Xu, Jing Qian, Su-Qin Zhang, Feng Xia, Hui-Jing Hu, Fei Xiao\",\"doi\":\"10.2147/DDDT.S494426\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Optimum dose of remimazolam for inducing loss of consciousness in elderly patients has been suggested by prior studies. Opioids can enhance their sedative effects, thereby permitting dose reduction. However, the dose-response of remimazolam when combined remifentanil for attenuating stress response during laryngeal mask airway (LMA) insertion in elderly female patients is still unknown. Moreover, the ideal dose of medications is especially critical in elderly patients due to their compromised cardiopulmonary function. The objective of this study was to determine the median effective dose (ED50) and ED95 of remimazolam in inhibiting the stress response associated with LMA insertion.</p><p><strong>Methods: </strong>Sixty aged ≥ 65 and < 80 years old female patients were randomized allocated into 1 of 4 groups receiving doses of 0.2, 0.25, 0.3, and 0.35 mg/kg remimazolam. Following a dosage of 2.0 ng/mL of remifentanil, patients received different doses of remimazolam. Effective dose is defined as the prevention of stress response associated with LMA insertion, characterized by a post-sedation induction SBP variation < 20% of baseline value, jaw relaxation and absence of patient body motion during the initial 2 minutes following LMA insertion. Probit regression analysis was utilized to estimate the ED50 and ED90 values.</p><p><strong>Results: </strong>The ED50 and ED95 of effective remimazolam of general induction for elderly female patients not suffer intubation stress response were 0.24 mg/kg (95% CI 0.20-0.27 mg/kg) and 0.37 mg/kg (95% CI 0.32-0.49 mg/kg), respectively. The incidence of hypotension was 33.3% (5/15), 46.7% (7/15), 73.3% (11/15), and 80% (12/15) in the four groups, respectively.</p><p><strong>Conclusion: </strong>The ED50 and ED95 values of intravenous remimazolam for preventing stress response during LMA insertion were 0.24 and 0.37 mg/kg, respectively in elderly female.</p><p><strong>Trial number and registry url: </strong>Registration number, ChiCTR2400083990, https://www.chictr.org.cn/showproj.html?proj=229006.</p>\",\"PeriodicalId\":11290,\"journal\":{\"name\":\"Drug Design, Development and Therapy\",\"volume\":\"19 \",\"pages\":\"1575-1583\"},\"PeriodicalIF\":5.1000,\"publicationDate\":\"2025-03-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11891449/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Drug Design, Development and Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2147/DDDT.S494426\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"CHEMISTRY, MEDICINAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug Design, Development and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2147/DDDT.S494426","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"CHEMISTRY, MEDICINAL","Score":null,"Total":0}
引用次数: 0
摘要
背景:以前的研究已经提出了雷马唑仑诱导老年患者意识丧失的最佳剂量。阿片类药物可以增强其镇静作用,从而允许减少剂量。然而,对于老年女性患者喉罩气道(LMA)置入时,雷马唑仑与瑞芬太尼联合用于减弱应激反应的剂量-反应尚不清楚。此外,由于老年患者心肺功能受损,理想的药物剂量尤其重要。本研究的目的是确定雷马唑仑抑制LMA插入相关应激反应的中位有效剂量(ED50)和ED95。方法:60例年龄≥65岁、< 80岁的女性患者随机分为4组,分别给予0.2、0.25、0.3、0.35 mg/kg的雷马唑仑治疗。在瑞芬太尼剂量为2.0 ng/mL后,患者接受不同剂量的瑞马唑仑。有效剂量定义为预防与LMA插入相关的应激反应,其特征是镇静后诱导收缩压变化<基线值的20%,下颌松弛,患者在LMA插入后的最初2分钟内没有身体运动。采用Probit回归分析估计ED50和ED90值。结果:老年女性患者无插管应激反应时,普通诱导有效雷马唑仑的ED50和ED95分别为0.24 mg/kg (95% CI 0.20 ~ 0.27 mg/kg)和0.37 mg/kg (95% CI 0.32 ~ 0.49 mg/kg)。四组患者低血压发生率分别为33.3%(5/15)、46.7%(7/15)、73.3%(11/15)、80%(12/15)。结论:老年女性静脉注射雷马唑仑预防LMA插入时应激反应的ED50和ED95分别为0.24和0.37 mg/kg。试用号和注册地址:注册号,ChiCTR2400083990, https://www.chictr.org.cn/showproj.html?proj=229006。
Dose-Response Study of Remimazolam Combined With Remifentanil for Attenuating Stress Response During Laryngeal Mask Airway Insertion in Elderly Female Patients: A Prospective Double-Blinded Study.
Background: Optimum dose of remimazolam for inducing loss of consciousness in elderly patients has been suggested by prior studies. Opioids can enhance their sedative effects, thereby permitting dose reduction. However, the dose-response of remimazolam when combined remifentanil for attenuating stress response during laryngeal mask airway (LMA) insertion in elderly female patients is still unknown. Moreover, the ideal dose of medications is especially critical in elderly patients due to their compromised cardiopulmonary function. The objective of this study was to determine the median effective dose (ED50) and ED95 of remimazolam in inhibiting the stress response associated with LMA insertion.
Methods: Sixty aged ≥ 65 and < 80 years old female patients were randomized allocated into 1 of 4 groups receiving doses of 0.2, 0.25, 0.3, and 0.35 mg/kg remimazolam. Following a dosage of 2.0 ng/mL of remifentanil, patients received different doses of remimazolam. Effective dose is defined as the prevention of stress response associated with LMA insertion, characterized by a post-sedation induction SBP variation < 20% of baseline value, jaw relaxation and absence of patient body motion during the initial 2 minutes following LMA insertion. Probit regression analysis was utilized to estimate the ED50 and ED90 values.
Results: The ED50 and ED95 of effective remimazolam of general induction for elderly female patients not suffer intubation stress response were 0.24 mg/kg (95% CI 0.20-0.27 mg/kg) and 0.37 mg/kg (95% CI 0.32-0.49 mg/kg), respectively. The incidence of hypotension was 33.3% (5/15), 46.7% (7/15), 73.3% (11/15), and 80% (12/15) in the four groups, respectively.
Conclusion: The ED50 and ED95 values of intravenous remimazolam for preventing stress response during LMA insertion were 0.24 and 0.37 mg/kg, respectively in elderly female.
Trial number and registry url: Registration number, ChiCTR2400083990, https://www.chictr.org.cn/showproj.html?proj=229006.
期刊介绍:
Drug Design, Development and Therapy is an international, peer-reviewed, open access journal that spans the spectrum of drug design, discovery and development through to clinical applications.
The journal is characterized by the rapid reporting of high-quality original research, reviews, expert opinions, commentary and clinical studies in all therapeutic areas.
Specific topics covered by the journal include:
Drug target identification and validation
Phenotypic screening and target deconvolution
Biochemical analyses of drug targets and their pathways
New methods or relevant applications in molecular/drug design and computer-aided drug discovery*
Design, synthesis, and biological evaluation of novel biologically active compounds (including diagnostics or chemical probes)
Structural or molecular biological studies elucidating molecular recognition processes
Fragment-based drug discovery
Pharmaceutical/red biotechnology
Isolation, structural characterization, (bio)synthesis, bioengineering and pharmacological evaluation of natural products**
Distribution, pharmacokinetics and metabolic transformations of drugs or biologically active compounds in drug development
Drug delivery and formulation (design and characterization of dosage forms, release mechanisms and in vivo testing)
Preclinical development studies
Translational animal models
Mechanisms of action and signalling pathways
Toxicology
Gene therapy, cell therapy and immunotherapy
Personalized medicine and pharmacogenomics
Clinical drug evaluation
Patient safety and sustained use of medicines.