瑞马唑仑预处理预防胃镜检查患者丙泊酚注射痛的效果。
Efficacy of pretreatment with remimazolam on prevention of propofol-induced injection pain in patients undergoing gastroscopy.
机构信息
Department of Anesthesiology, Jinan Central Hospital, Central Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, China.
Department of Urology, Jinan Central Hospital, Central Hospital Affiliated to Shandong First Medical University, No.105 JieFang Road, Jinan, 250013, Shandong, China.
出版信息
Sci Rep. 2023 Nov 11;13(1):19683. doi: 10.1038/s41598-023-47151-3.
To evaluate the efficacy of remimazolam pretreatment in preventing propofol-induced injection pain (PIP) in patients undergoing gastroscopy. One hundred and forty patients (ASA I-II, aged 18-65 years, BMI 18-28 kg/m) who were to undergo gastroscopy were randomized into either a saline group (group S) or a remimazolam group (group R) (n = 70 for each) on a computer-generated random number basis. The patients in group S received normal saline (0.1 ml/kg) and those in group R were administered remimazolam (0.1 mg/kg) via intravenous infusion for 60 s. 30 s after the injection of normal saline or remimazolam, patients received intravenously propofol (0.5 ml/s) until loss of consciousness. A different anesthesiologist who was unaware of the pretreatment was responsible for maintaining the outcome. The primary endpoint of our study was the incidence of PIP, which was measured using a 4-point scale. Secondary endpoints include the intensity of PIP, vital signs, characteristics of surgery and recovery, and adverse events. The incidence of PIP was significantly lower in group R than in group S (13 vs 51%, p < 0.001), and a lower percentage of patients presented with moderate PIP (3 vs 20%, p < 0.001). Moreover, lower consumption of propofol, shorter recovery time, and greater patient satisfaction were observed in group R than in group S. Pretreatment with remimazolam can effectively reduce the incidence and intensity of PIP in gastroscopy and shorten the recovery time without severe adverse effects.Clinical Trials Registration: Trial Registration: Chinese Clinical Trial Registry (identifier: ChiCTR2200063793). Registry time: 16/09/2022. Registry name: Efficacy of Pre-Treatment with Remimazolam on Prevention of Propofol-Induced Injection Pain in Patients Undergoing Gastroscopy. The date of patient enrollment began from 2022-9-17 to 2022-10-10. The link to the registration: https://www.chictr.org.cn/showproj.html?proj=176004 .
为了评估 remimazolam 预处理预防胃镜检查中丙泊酚诱导注射痛（PIP）的疗效。将 140 名（ASA I-II，年龄 18-65 岁，BMI 18-28kg/m）接受胃镜检查的患者按计算机生成的随机数分为生理盐水组（S 组）或 remimazolam 组（R 组）（每组 n=70）。S 组患者给予生理盐水（0.1ml/kg），R 组患者静脉输注 remimazolam（0.1mg/kg）60s。生理盐水或 remimazolam 注射后 30s，患者以 0.5ml/s 静脉注射丙泊酚直至意识丧失。负责维持结果的是一位不知道预处理的不同麻醉师。本研究的主要终点是 PIP 的发生率，采用 4 分制测量。次要终点包括 PIP 的强度、生命体征、手术和恢复的特点以及不良事件。R 组 PIP 的发生率明显低于 S 组（13%比 51%，p<0.001），且中度 PIP 的患者比例较低（3%比 20%，p<0.001）。此外，R 组丙泊酚用量较低，恢复时间较短，患者满意度较高。Remimazolam 预处理可有效降低胃镜检查中 PIP 的发生率和强度，缩短恢复时间，且无严重不良事件。临床试验注册：试验注册：中国临床试验注册中心（标识符：ChiCTR2200063793）。注册时间：2022 年 9 月 16 日。注册名称：Remimazolam 预处理对预防胃镜检查中丙泊酚诱导注射痛的疗效。患者入组日期为 2022 年 9 月 17 日至 2022 年 10 月 10 日。注册链接：https://www.chictr.org.cn/showproj.html?proj=176004。
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