Prospective analysis of efficacy and safety of an individualized-midazolam-dosing protocol for sedation during prolonged bronchoscopy.
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.
Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: tomomi.ogawa0616@gmail.com.
Tomomi
T
Ogawa
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.
Kazuyoshi
K
Imaizumi
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.
Izumi
I
Hashimoto
Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: yshindo@med.nagoya-u.ac.jp.
Yuichiro
Y
Shindo
Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: naoi6014@med.nagoya-u.ac.jp.
Naoyuki
N
Imai
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.
Sakurako
S
Uozu
Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: tshimo@med.nagoya-u.ac.jp.
Tomoya
T
Shimokata
Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: itori@med.nagoya-u.ac.jp.
Satoru
S
Ito
Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: hashinao@med.nagoya-u.ac.jp.
Naozumi
N
Hashimoto
Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: msato@med.nagoya-u.ac.jp.
Mitsuo
M
Sato
Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: mkond@med.nagoya-u.ac.jp.
Masashi
M
Kondo
Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan. Electronic address: yhasega@med.nagoya-u.ac.jp.
Yoshinori
Y
Hasegawa
D000328:Adult; D000368:Aged; D001999:Bronchoscopy / Q000379:methods*; D016292:Procedural Sedation / Q000379:methods*; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage*; D008297:Male; D008874:Midazolam / Q000008:administration & dosage*; D008875:Middle Aged; D016343:Monitoring, Intraoperative; D061646:Operative Time; D057285:Precision Medicine / Q000379:methods*; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D055986:Vital Signs; D055815:Young Adult
D006993:Hypnotics and Sedatives; D008874:Midazolam
Bronchoscopy; Midazolam; Prospective study; Questionnaire; Sedation