老年患者中舒芬太尼抑制喉罩插入反应的半数有效剂量的测定：一项前瞻性、双盲、剂量反应试验。
Determination of the median effective dose of sufentanil for inhibiting the laryngeal mask insertion response in geriatric patients: a prospective, double-blinded, dose-response trial.
机构信息
Department of Anesthesiology, The Affiliated AnQing Municipal Hospitals of Anhui Medical University, 352th, Renming Road, AnQing, 246003, AnHui Province, China.
出版信息
BMC Anesthesiol. 2022 Jul 11;22(1):216. doi: 10.1186/s12871-022-01758-7.
BACKGROUND
Laryngeal mask airway(LMA) have been widely used in clinical practice. Irritation to the patient during the insertion of a laryngeal mask can cause hemodynamic fluctuations, which is particularly unsafe for geriatric patients. We used probit regression analysis to determine the median effective dose of sufentanil to inhibit the response to LMA insertion in geriatric patients.
METHODS
A total of 90 patients were selected for the study using the following inclusion criteria: age ≥ 65 years old, ASA grade I-III, and scheduled to undergo intravenous general anesthesia with LMA insertion. Each patient received a dose of sufentanil for anesthesia induction in one of six levels: 0.05, 0.1, 0.15, 0.2, 0.25, or 0.3 μg kg. LMA insertion was scored with a 3-point, 6-category scale, with scores ≥ 16 indicating effective LMA insertion, and < 16 indicating ineffective LMA insertion. Mean arterial blood pressure (MAP), heart rate (HR), and bispectral index (BIS) were recorded 1 min before induction (T1), 1 min after induction (T2), 1 min after LMA insertion (T3), and 5 min after LMA insertion (T4) in each group. In addition, the plasma norepinephrine (NE) levels and adverse reactions were measured at T2 and T3 in each dosage group.
RESULTS
Probit regression analysis showed that the ED50 of sufentanil inhibiting the response to LMA insertion in geriatric patients was 0.18 μg kg (95% CI: 0.16-0.21 μg kg), and the ED95 was 0.31 μg kg (95% CI: 0.27-0.38 μg kg), and the probit(p) = -2.34 + 12.90 × ln(Dose)([Formula: see text] = 0.725, p = 0.948). Among all the patients, the number of effective LMA insertions was 57 (group A), and the number of ineffective LMA insertions was 33 (group B). The MAP, HR, and NE in group B were significantly higher than in group A at T3.
CONCLUSIONS
Sufentanil can effectively inhibit the patient's response to LMA insertion, with stable hemodynamics and small stress response. The ED50 and ED95 were 0.18 μg kg (95% CI: 0.16-0.21 μg kg) and 0.31 μg kg(95% CI: 0.27-0.38 μg kg), respectively.
TRIAL REGISTRATION
This study was registered in the Chinese Clinical Trial Registry (Registration number: ChiCTR2100051827 ) on October 6, 2021.
背景
喉罩（LMA）已广泛应用于临床实践。在插入喉罩时对患者的刺激会引起血流动力学波动，这对老年患者尤其不安全。我们使用概率回归分析来确定舒芬太尼抑制老年患者对喉罩插入反应的中效剂量。
方法
本研究共纳入 90 例符合以下纳入标准的患者：年龄≥65 岁，ASA 分级 I-III 级，拟行静脉全身麻醉下插入喉罩。每位患者在六个水平之一接受舒芬太尼麻醉诱导剂量：0.05、0.1、0.15、0.2、0.25 或 0.3μg/kg。LMA 插入采用 3 分 6 级评分，评分≥16 表示 LMA 插入有效，评分<16 表示 LMA 插入无效。在每组中，记录以下时间点的平均动脉血压（MAP）、心率（HR）和脑电双频指数（BIS）：诱导前 1 分钟（T1）、诱导后 1 分钟（T2）、LMA 插入后 1 分钟（T3）和 LMA 插入后 5 分钟（T4）。此外，在每个剂量组的 T2 和 T3 时测量血浆去甲肾上腺素（NE）水平和不良反应。
结果
概率回归分析显示，舒芬太尼抑制老年患者对喉罩插入反应的 ED50 为 0.18μg/kg（95%CI：0.16-0.21μg/kg），ED95 为 0.31μg/kg（95%CI：0.27-0.38μg/kg），概率（p）=-2.34+12.90×ln（剂量）[公式：见正文]（[Formula: see text] = 0.725，p = 0.948）。在所有患者中，57 例（A 组）LMA 插入有效，33 例（B 组）LMA 插入无效。B 组在 T3 时的 MAP、HR 和 NE 明显高于 A 组。
结论
舒芬太尼可有效抑制患者对喉罩插入的反应，血流动力学稳定，应激反应小。ED50 和 ED95 分别为 0.18μg/kg（95%CI：0.16-0.21μg/kg）和 0.31μg/kg（95%CI：0.27-0.38μg/kg）。
试验注册
本研究于 2021 年 10 月 6 日在中国临床试验注册中心（注册号：ChiCTR2100051827）注册。
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