Tomomi Ogawa1, Kazuyoshi Imaizumi2, Izumi Hashimoto3, Yuichiro Shindo4, Naoyuki Imai5, Sakurako Uozu6, Tomoya Shimokata7, Satoru Ito8, Naozumi Hashimoto9, Mitsuo Sato10, Masashi Kondo11, Yoshinori Hasegawa12. 1. Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: tomomi.ogawa0616@gmail.com. 2. Division of Respiratory Medicine and Clinical Allergy, Department of Internal Medicine, Fujita Health University, Toyoake, Aichi 470-1192, Japan. Electronic address: jeanluc@fujita-hu.ac.jp. 3. Division of Respiratory Medicine and Clinical Allergy, Department of Internal Medicine, Fujita Health University, Toyoake, Aichi 470-1192, Japan. Electronic address: izumi-hashimoto@gate.sws.co.jp. 4. Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: yshindo@med.nagoya-u.ac.jp. 5. Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: naoi6014@med.nagoya-u.ac.jp. 6. Division of Respiratory Medicine and Clinical Allergy, Department of Internal Medicine, Fujita Health University, Toyoake, Aichi 470-1192, Japan. Electronic address: suozu@med.nagoya-u.ac.jp. 7. Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: tshimo@med.nagoya-u.ac.jp. 8. Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: itori@med.nagoya-u.ac.jp. 9. Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: hashinao@med.nagoya-u.ac.jp. 10. Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: msato@med.nagoya-u.ac.jp. 11. Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: mkond@med.nagoya-u.ac.jp. 12. Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: yhasega@med.nagoya-u.ac.jp.
Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Authors: Elise Orvedal Leiten; Tomas Mikal Lind Eagan; Einar Marius Hjellestad Martinsen; Eli Nordeide; Gunnar Reksten Husebø; Kristel Svalland Knudsen; Sverre Lehmann; Øistein Svanes; Per Sigvald Bakke; Rune Nielsen Journal: BMJ Open Respir Res Date: 2020-03