Prospective analysis of efficacy and safety of an individualized-midazolam-dosing protocol for sedation during prolonged bronchoscopy

Tomomi Ogawa, Kazuyoshi Imaizumi, Izumi Hashimoto, Yuichiro Shindo, Naoyuki Imai, Sakurako Uozu, Tomoya Shimokata, Satoru Ito, Naozumi Hashimoto, Mitsuo Sato, Masashi Kondo, Yoshinori Hasegawa

Research output: Contribution to journalArticle

8 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)153-159
Number of pages7
JournalRespiratory Investigation
Volume52
Issue number3
DOIs
Publication statusPublished - 01-01-2014

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Midazolam
Bronchoscopy
Safety
Anxiety
Oxygen
Vital Signs
Electrocardiography
Blood Pressure

All Science Journal Classification (ASJC) codes

  • Pulmonary and Respiratory Medicine

Cite this

Ogawa, Tomomi ; Imaizumi, Kazuyoshi ; Hashimoto, Izumi ; Shindo, Yuichiro ; Imai, Naoyuki ; Uozu, Sakurako ; Shimokata, Tomoya ; Ito, Satoru ; Hashimoto, Naozumi ; Sato, Mitsuo ; Kondo, Masashi ; Hasegawa, Yoshinori. / Prospective analysis of efficacy and safety of an individualized-midazolam-dosing protocol for sedation during prolonged bronchoscopy. In: Respiratory Investigation. 2014 ; Vol. 52, No. 3. pp. 153-159.
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Ogawa, T, Imaizumi, K, Hashimoto, I, Shindo, Y, Imai, N, Uozu, S, Shimokata, T, Ito, S, Hashimoto, N, Sato, M, Kondo, M & Hasegawa, Y 2014, 'Prospective analysis of efficacy and safety of an individualized-midazolam-dosing protocol for sedation during prolonged bronchoscopy', Respiratory Investigation, vol. 52, no. 3, pp. 153-159. https://doi.org/10.1016/j.resinv.2013.09.003

Prospective analysis of efficacy and safety of an individualized-midazolam-dosing protocol for sedation during prolonged bronchoscopy. / Ogawa, Tomomi; Imaizumi, Kazuyoshi; Hashimoto, Izumi; Shindo, Yuichiro; Imai, Naoyuki; Uozu, Sakurako; Shimokata, Tomoya; Ito, Satoru; Hashimoto, Naozumi; Sato, Mitsuo; Kondo, Masashi; Hasegawa, Yoshinori.

In: Respiratory Investigation, Vol. 52, No. 3, 01.01.2014, p. 153-159.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Prospective analysis of efficacy and safety of an individualized-midazolam-dosing protocol for sedation during prolonged bronchoscopy

AU - Ogawa, Tomomi

AU - Imaizumi, Kazuyoshi

AU - Hashimoto, Izumi

AU - Shindo, Yuichiro

AU - Imai, Naoyuki

AU - Uozu, Sakurako

AU - Shimokata, Tomoya

AU - Ito, Satoru

AU - Hashimoto, Naozumi

AU - Sato, Mitsuo

AU - Kondo, Masashi

AU - Hasegawa, Yoshinori

PY - 2014/1/1

Y1 - 2014/1/1

N2 - 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.

AB - 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.

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