Cha Bao-Zhu, Hu Shuang-Yan, Chen Nian-Ping, Cao Jia-Fei, Xu Cheng, Qiu Kai, Luo Foquan
Department of Anesthesiology, Affiliated Hospital of Shaoxing University, Shaoxing, 312000, China.
Department of Anesthesiology, Shaoxing People's Hospital, Shaoxing, 312000, China.
BMC Anesthesiol. 2025 Jul 29;25(1):363. doi: 10.1186/s12871-025-03235-3.
This study aimed to evaluate the impact of anxiety on the pharmacodynamics of remimazolam besylate in patients undergoing gastroscopy.
Patients undergoing gastroscopy were divided into two groups: an anxiety group (Self -rating Anxiety scale, SAS ≥ 50) and a non-anxiety group (SAS < 50). All patients received intravenous administration of 5 µg/kg alfentanil combined with remimazolam besylate. The biased coin design up-and-down sequential method (BCD-UDM) was used to determine the target doses of remimazolam besylate: the initial dose was 0.1 mg/kg, with a dose gradient of 0.01 mg/kg. If coughing, swallowing, or body movement reactions occurred within the first 2 min from the start of gastroscopy, it was considered a positive reaction, and the dose was increased for the next patient. Otherwise, it was considered a negative reaction, and the dose of remimazolam besylate for the next patient was determined according to the BCD-UDM. Discharge time from the recovery room and adverse reactions were recorded. The ED, ED, and their 95% confidence intervals (CI) were calculated.
The ED and ED of remimazolam besylate in the anxiety group were 0.175 mg/kg (95% CI, 0.140-0.240) and 0.251 mg/kg (95% CI, 0.173-0.250), respectively. In contrast, the ED and ED of remimazolam besylate in the non-anxiety group were 0.126 mg/kg (95% CI, 0.116-0.150) and 0.148 mg/kg (95% CI, 0.130-0.160), respectively. The ED equivalent ratio of the non-anxiety group to the anxiety group was 0.59 (95% CI, 0.468-0.710). The discharge time from the recovery room and the incidence of adverse reactions did not differ significantly between the groups.
When combined with 5 µg/kg alfentanil, the ED and ED of remimazolam besylate for inhibiting body movement response within two minutes of gastroscopy in anxious patients were 0.175 mg/kg and 0.251 mg/kg, respectively. Anxiety increased the requirement for remimazolam besylate in patients undergoing gastroscopy, but it did not increase the risk of prolonged discharge time or adverse effects.
The study was registered in the Chinese Clinical Trial Registry. (ChiCTR2400086957) on July 15, 2024.
本研究旨在评估焦虑对接受胃镜检查患者中苯磺酸瑞马唑仑药效学的影响。
将接受胃镜检查的患者分为两组：焦虑组（自评焦虑量表，SAS≥50）和非焦虑组（SAS<50）。所有患者均接受静脉注射5μg/kg阿芬太尼联合苯磺酸瑞马唑仑。采用偏倚硬币设计上下序贯法（BCD-UDM）确定苯磺酸瑞马唑仑的目标剂量：初始剂量为0.1mg/kg，剂量梯度为0.01mg/kg。若在胃镜检查开始后的前2分钟内出现咳嗽、吞咽或身体运动反应，则视为阳性反应，下一位患者的剂量增加。否则，视为阴性反应，并根据BCD-UDM确定下一位患者的苯磺酸瑞马唑仑剂量。记录从恢复室出院的时间和不良反应。计算ED、ED及其95%置信区间（CI）。
焦虑组中苯磺酸瑞马唑仑的ED和ED分别为0.175mg/kg（95%CI，0.140-0.240）和0.251mg/kg（95%CI，0.173-0.250）。相比之下，非焦虑组中苯磺酸瑞马唑仑的ED和ED分别为0.126mg/kg（95%CI，0.116-0.150）和0.148mg/kg（95%CI，0.130-0.160）。非焦虑组与焦虑组的ED等效比为0.59（95%CI，0.468-0.710）。两组之间从恢复室出院的时间和不良反应发生率无显著差异。
当与5μg/kg阿芬太尼联合使用时，焦虑患者在胃镜检查两分钟内抑制身体运动反应的苯磺酸瑞马唑仑的ED和ED分别为0.175mg/kg和0.251mg/kg。焦虑增加了接受胃镜检查患者对苯磺酸瑞马唑仑的需求，但并未增加延长出院时间或不良反应的风险。
该研究于2024年7月15日在中国临床试验注册中心注册。（ChiCTR2400086957）
