瑞马唑仑复合舒芬太尼用于麦默通乳腺微创手术中的有效剂量评估

Evaluation of effective dose of remimazolam combined with sufentanil in Mammotome surgery

关键词:  瑞马唑仑  舒芬太尼  麦默通乳腺微创手术  半数有效剂量

Key words:  remimazolam  sufentanil  Mammotome minimally invasive breast surgery  half effective dose

摘要:

目的 测定瑞马唑仑复合舒芬太尼用于麦默通乳腺微创手术中的半数有效剂量（ED₅₀）及95%有效剂量（ED₉₅）。方法 选择2021年10月至2022年3月在武汉市中心医院行麦默通乳腺微创手术治疗的女性患者24例，年龄（36.12±11.08）岁，体重（56.17±7.22）kg，身高（161.71±11.08）cm，美国麻醉师协会 （ASA） 分级Ⅰ或Ⅱ级，根据Dixon改良序贯法，所有患者麻醉前缓慢静脉注射舒芬太尼0.1 μg/kg，3 min后注射瑞马唑仑0.2 mg/kg，待睫毛反射消失后局部注射利多卡因3～5 mL，而后行麦默通乳腺微创手术，若在局部注射利多卡因或手术操作过程中患者出现呛咳、皱眉、吞咽、体动影响手术操作等反应示为阳性反应，则下一例患者使用剂量增加0.02 mg/kg，否则降低0.02 mg/kg，以阳性反应转为阴性反应为交叉点，当出现7个交叉点时终止研究。统计学分析采用概率单位回归分析法计算。记录患者入室后（T₀）的平均动脉压（MAP）、心率（HR）、脉搏血氧饱和度（SpO₂），记录舒芬太尼静脉注射后3 min（T₁）、瑞马唑仑静脉注射后1 min（T₂）、局部注射利多卡因后（T₃）、手术开始时（T₄）、手术结束时（T₅）的MAP、HR和SpO₂。结果 瑞马唑仑抑制麦默通乳腺微创手术患者体动反应的ED₅₀为0.207 mg/kg（95%CI 0.177～0.236 mg/kg），ED₉₅为0.251 mg/kg（95%CI 0.128～0.529 mg/kg），与T₀比较，T₂时刻的SpO₂和HR无明显变化（P＞0.05），而MAP明显下降（P＜0.05），但下降幅度小于基础值的20%。结论 瑞马唑仑复合舒芬太尼用于麦默通乳腺微创手术的ED50为0.207 mg/kg，患者术中呼吸循环系统稳定，镇静效果确切，术后无不良反应发生。

Abstract:

Objective To determine the 50% effective dose (ED₅₀) and 95% effective dose (ED₉₅) of remimazolam combined with sufentanil in Mammotome breast minimally invasive surgery. Methods A total of 24 female patients with average age (36.12±11.08) years old, weight (56.17±7.22) kg, and height (161.71±11.08) cm, who received Mammotome surgery in Wuhan Central Hospital from October 2021 to March 2022, were selected. They were rated grade Ⅰ or Ⅱ by The American Society of Anesthesiologists. According to Dixon's modified sequence method, 0.1 μg/kg sufentanil was slowly injected intravenously before anesthesia, 0.2 mg/kg rimazolam was injected 3 min later, 3-5 mL lidocaine was then locally injected after eyelash reflection disappeared before Mammotome breast minimally invasive surgery. If during the local injection of lidocaine or surgical operation, the patient had cough, frowning, swallowing, or other reactions affecting the surgical procedure, they were considered as positive reactions. The dose in the next patient was increased by 0.02 mg/kg, otherwise it was decreased by 0.02 mg/kg. The crossover point was defined as positive reaction to negative reaction, and the study was terminated when there were seven crossover points. Statistical analysis was performed by Probit regression analysis. Mean arterial pressure (MAP), heart rate (HR), and blood oxygen saturation (SpO₂) were recorded after entering the operation room (T₀), 3 min after sufentanil administration (T₁), 1 min after remimazolam administration (T₂), local injection of lidocaine (T₃), the beginning of surgery (T₄) and the end of surgery (T₅). Results The ED₅₀ and ED₉₅ of remimazolam for Mammotome minimally invasive breast surgery were 0.207 mg/kg (95%CI 0.177-0.236 mg/kg) and 0.251 mg/kg (95%CI 0.228-0.529 mg/kg), respectively. Compared with T₀, HR and SpO₂ at T₂ had no significant change (P＞0.05), while MAP decreased significantly (P＜0.05), but the decrease was less than 20% of the base value. Conclusion The ED₅₀ of remimazolam combined with sufentanil for Mammotome breast minimally invasive surgery is 0.207 mg/kg. The patient's respiratory and circulatory system is stable and the sedation effect is accurate, and no postoperative adverse reactions occur.