瑞马唑仑联合瑞芬太尼减轻老年女性患者喉罩置入期间应激反应的剂量反应研究：一项前瞻性双盲研究
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.
作者信息
Xu Qiang, Qian Jing, Zhang Su-Qin, Xia Feng, Hu Hui-Jing, Xiao Fei
机构信息
Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing City, Zhejiang Province, People's Republic of China.
出版信息
Drug Des Devel Ther. 2025 Mar 5;19:1575-1583. doi: 10.2147/DDDT.S494426. eCollection 2025.
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.
背景
先前的研究已提出老年患者诱导意识丧失时瑞马唑仑的最佳剂量。阿片类药物可增强其镇静作用，从而允许减少剂量。然而，老年女性患者在插入喉罩气道（LMA）期间联合使用瑞芬太尼时瑞马唑仑的剂量反应仍不清楚。此外，由于老年患者心肺功能受损，理想的药物剂量尤为关键。本研究的目的是确定瑞马唑仑抑制与LMA插入相关的应激反应的半数有效剂量（ED50）和ED95。
方法
60名年龄≥65岁且<80岁的老年女性患者被随机分为4组，分别接受0.2、0.25、0.3和0.35mg/kg的瑞马唑仑剂量。在给予2.0ng/mL的瑞芬太尼后，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，其特征为镇静诱导后收缩压变化<基线值的20%、下颌松弛且在插入LMA后的最初2分钟内患者无身体运动。采用概率回归分析来估计ED50和ED90值。
结果
未遭受插管应激反应的老年女性患者全身诱导有效瑞马唑仑的ED50和ED95分别为0.24mg/kg（95%CI 0.20 - 0.27mg/kg）和0.37mg/kg（95%CI 0.32 - 0.49mg/kg）。四组中低血压的发生率分别为33.3%（5/15）、46.7%（7/15）、73.3%（11/15）和80%（12/15）。
结论
老年女性静脉注射瑞马唑仑预防LMA插入期间应激反应的ED50和ED95值分别为0.24和0.37mg/kg。
试验编号和注册网址
注册号，ChiCTR2400083990，https://www.chictr.org.cn/showproj.html?proj=229006
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