Ogawa Tomomi, Imaizumi Kazuyoshi, Hashimoto Izumi, Shindo Yuichiro, Imai Naoyuki, Uozu Sakurako, Shimokata Tomoya, Ito Satoru, Hashimoto Naozumi, Sato Mitsuo, Kondo Masashi, Hasegawa Yoshinori
Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Division of Respiratory Medicine and Clinical Allergy, Department of Internal Medicine, Fujita Health University, Toyoake, Aichi 470-1192, Japan.
Respir Investig. 2014 May;52(3):153-9. doi: 10.1016/j.resinv.2013.09.003. Epub 2013 Nov 9.
Newer more advanced techniques in bronchoscopy may require longer procedure times, although a standard protocol for sedation during prolonged bronchoscopy has not yet been defined.
We designed a prospective, non-randomized, single-arm study (UMIN trial number 000003971) using patient questionnaires and vital sign monitoring to assess the efficacy and safety of a standardized midazolam dosing protocol based on gender and age for use during bronchoscopy. The loading dose of midazolam was 0.075mg/kg for men ≤65 years old and women ≤70 and 0.05mg/kg for men ≥66 years and women ≥71 years, with subsequent doses of one-half the loading dose to be administered every 20min. The primary endpoint was tolerability and secondary endpoints included anxiety and recall of procedure, willingness to undergo repeat procedure, and complications. Safety was evaluated in terms of monitored changes in blood pressures, ECG, oxygen saturation, and CO2 content in expiration during the procedure.
A total of 204 patients were included in the study. Overall, 163 patients (79.9%) reported "no distress" during the procedure, 185 patients (90.7%) reported "no anxiety," and 175 (85.8%) replied that they would accept a repeat procedure, if necessary. The mean minimum oxygen saturation was 90.2% and the mean maximum expiratory CO2 level was 37.7mmHg. There were no serious complications related to the protocol.
The midazolam dosing protocol examined in this study was safe and effective. It is simple, and it could easily be translated to routine clinical practice.
支气管镜检查中更新、更先进的技术可能需要更长的操作时间，不过长时间支气管镜检查期间的标准镇静方案尚未确定。
我们设计了一项前瞻性、非随机、单臂研究（UMIN试验编号000003971），使用患者问卷和生命体征监测来评估基于性别和年龄的标准化咪达唑仑给药方案在支气管镜检查期间的疗效和安全性。≤65岁男性和≤70岁女性的咪达唑仑负荷剂量为0.075mg/kg，≥66岁男性和≥71岁女性的负荷剂量为0.05mg/kg，随后每20分钟给予负荷剂量的一半。主要终点是耐受性，次要终点包括焦虑和对操作的回忆、接受重复操作的意愿以及并发症。通过监测操作期间血压、心电图、血氧饱和度和呼气中二氧化碳含量的变化来评估安全性。
共有204例患者纳入研究。总体而言，163例患者（79.9%）在操作期间报告“无不适”，185例患者（90.7%）报告“无焦虑”，175例（85.8%）回答如有必要他们会接受重复操作。平均最低血氧饱和度为90.2%，平均最大呼气二氧化碳水平为37.7mmHg。没有与该方案相关的严重并发症。
本研究中检查的咪达唑仑给药方案安全有效。它简单易行，可轻松转化为常规临床实践。
