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Received:October 26, 2024 Published Online:June 20, 2025
Received:October 26, 2024 Published Online:June 20, 2025
中文摘要: 目的 探讨瑞马唑仑用于臂丛神经阻滞（BPB）辅助镇静的95%有效剂量（ED95）及其有效性、安全性，并与丙泊酚比较。方法 选择长江大学附属荆州医院2023年12月至2024年5月接受择期BPB下行上肢手术的患者进行两部分临床试验。第一部分用偏币序贯法研究瑞马唑仑和丙泊酚BPB辅助镇静的ED95，选择100例患者，随机分为瑞马唑仑组（R1组）和丙泊酚组（B1组），各50例。镇静辅助用药：R1组负荷剂量为0.1 mg/kg，起始维持剂量为0.1 mg·kg-1·h-1，剂量梯度为0.02 mg·kg-1·h-1；B1组负荷剂量为1 mg/kg，起始维持剂量为3 mg·kg-1·h-1，剂量梯度为0.2 mg·kg-1·h-1。采用Probit概率回归计算瑞马唑仑和丙泊酚的ED95及95%CI。第二部分比较两药ED95有效性、安全性，选择62例患者，随机分为瑞马唑仑组（R2组）和丙泊酚组（B2组），各31例。镇静辅助用药：R2组负荷剂量为0.1 mg/kg，B2组负荷剂量为1 mg/kg，继而两组均以ED95剂量泵注维持至外科医生缝皮时。记录各时点［给药前（T0），负荷量完成时（T1），给药后10、15、30 min（T2、T3、T4），停药时（T5），手术结束时（T6）］的平均动脉压（MAP）、心率（HR）、脉搏血氧饱和度（SpO2）及改良警觉/镇静评分（MOAA/S），记录两组患者低血压发生率、MAP的血压变异性（BPV）、清醒时间及不良反应。结果 瑞马唑仑（R1组）和丙泊酚（B1组）用于BPB辅助镇静的ED95分别为0.310 mg·kg-1·h-（1 95%CI：0.281~0.486 mg·kg-1·h-1）、5.564 mg·kg-1·h-（1 95%CI：5.101~10.478 mg·kg-1·h-1）。与B2组比较，R2组镇静期间MAP、HR较高，清醒时间较早，BPV值、低血压、低氧血症和注射痛发生率较低，差异均有统计学意义（P＜0.05）；R2组的MOAA/S 评分仅在T5时高于B2组（P＜0.05）。结论 瑞马唑仑用于BPB辅助镇静的ED95为0.310 mg·kg-1·h-1，与等同剂量的丙泊酚相比，其镇静作用明显，对生命体征影响小，不良反应少。
Abstract:Objective To investigate the 95% effective dose（ED95）of remimazolam for brachial plexus block（BPB）-assisted sedation and its effectiveness and safety, and to compare it with propofol. Methods Two-part clinical trials were conducted in patients undergoing elective BPB for upper limb surgery from December 2023 to May 2024 at Jingzhou Hospital Affiliated to Yangtze University. In the first part, using the biased coin up ? and ? down sequential allocation method to study the ED95 of remimazolam and propofol for BPB assisted sedation, 100 patients were randomly divided into remimazolam group（R1 group）and propofol group（B1 group）, with 50 cases in each group. Sedative adjuvant medication：the R1 group received a loading dose of 0.1 mg/kg and an initial maintenance dose of 0.1 mg·kg-1·h-1, with a dose gradient of 0.02 mg·kg-1·h-1. The B1 group received a loading dose of 1 mg/kg and an initial maintenance dose of3 mg·kg-1·h-1, with a dose gradient of 0.2 mg·kg-1·h-1. Probit probabilistic regression was used to calculate the ED95 and patients were randomly divided into remimazolam group（R2 group）and propofol group（B2 group）, with 31 cases ineach group. Sedative adjuvant medication：the loading dose was 0.1 mg/kg in the R2 group and 1 mg/kg in the B2group, and then both groups were pumped with ED95 dose until suturing. The mean arterial pressure（MAP）, heart rate（HR）, pulse oxygen saturation（SpO2）and modified observer’s assessment of alertness/sedation（MOAA/S）score were recorded at each time point［before administration（T0）, completion of loading（T1）, 10, 15, 30 min after administration （T2, T3, T4）, drug withdrawal（T5）, the end of surgery（T6）］, and the incidence of hypotension, blood pressure variability（BPV）of MAP, waking time and adverse reactions were recorded in the two groups.Results The ED95 values for remimazolam and propofol were 0.310 mg·kg-1·h-1（95% CI：0.281?0.486 mg·kg-1·h-1）and 5.564 mg·kg-1·h-1（95% CI：5.101?10.478 mg·kg-1·h-1）, respectively. Compared with B2 group, R2 group had higher MAP and HR during sedation, earlier awake time, lower BPV value, lower incidence of hypotension, hypoxemiaand injection pain, with statistical significances（P<0.05）. The MOAA/S score of R2 group was higher than that of B2group only at T5（P<0.05）. Conclusion The ED95 for remimazolam in BPB-assisted sedation is 0.310 mg·kg- 1·h- 1.Compared to the same dose of propofol, remimazolam has obvious sedative effect, little influence on vital signs and fewer adverse reactions.
文章编号： 中图分类号：R614.4 文献标志码：A
基金项目:
| Author Name | Affiliation |
| SI Zenghao，WANG Jinfeng，GAO Yuan，CHEN Bowen，WANG Weilian，ZHANG Kun | Department of Anesthesiology，Jinzhou Hospital Affiliated to Yangtze University，Jingzhou，Hubei 434000，China |
| Author Name | Affiliation |
| SI Zenghao，WANG Jinfeng，GAO Yuan，CHEN Bowen，WANG Weilian，ZHANG Kun | Department of Anesthesiology，Jinzhou Hospital Affiliated to Yangtze University，Jingzhou，Hubei 434000，China |
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