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Войти в исследования Lung cancer (Amsterdam, Netherlands) · 2025
Midazolam with fentanyl for endobronchial ultrasound-guided transbronchial needle aspiration: a randomized, double-blind, phase III study.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыНазвание и аннотация: Перевод в очереди
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Yamada Jun, Hazama Daisuke, Fukui Takafumi, Yatani Atsuhiko, Okamoto Mariko, Fujimoto Shodai, Yoshimura Ryosuke, Takayasu Mizuki, Takata Naoya, Sato Hiroki, Mimura Chihiro, Furukawa Koichi, Katsurada Naoko, Yamamoto Masatsugu, Tachihara Motoko
Аннотация
BACKGROUND: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a common technique for sampling mediastinal and hilar lymph nodes. However, the optimal sedation for EBUS-TBNA remains unclear. We aimed to evaluate the efficacy of adding fentanyl to midazolam.
MATERIALS AND METHODS: We conducted a single-center, randomized, double-blind, phase III study. Patients who received midazolam with fentanyl (fentanyl group) were compared with those who received midazolam with placebo (placebo group) during EBUS-TBNA. The primary outcome was the proportion of patients meeting all three criteria: 1) adequate sedation (Modified Observer's Assessment of Alertness and Sedation scale ≤4 or bispectral index values ≤80), 2) minimal additional sedation requirement (no more than two additional sedative administrations within the first 30 min), and 3) successful procedure completion (at least three EBUS-TBNA punctures).
RESULTS: A total of 84 patients (fentanyl group, 41; placebo group, 43) were enrolled. There were no significant differences in patient characteristics between the two groups. The primary outcome was significantly better in the fentanyl group than in the placebo group (46.3 % vs. 23.3 %, p = 0.038). A significantly lower rate of sedative-induced delirium, a lower number of additional sedative administrations, and a higher rate of ≥3 punctures were observed in the fentanyl group. There were no significant differences in complications. The operator visual analog scale questionnaire on cough, sputum, cooperation, and sedative effects was significantly better in the fentanyl group.
CONCLUSION: Adding fentanyl to midazolam provided better sedation. Midazolam combined with fentanyl should be considered during EBUS-TBNA.
MATERIALS AND METHODS: We conducted a single-center, randomized, double-blind, phase III study. Patients who received midazolam with fentanyl (fentanyl group) were compared with those who received midazolam with placebo (placebo group) during EBUS-TBNA. The primary outcome was the proportion of patients meeting all three criteria: 1) adequate sedation (Modified Observer's Assessment of Alertness and Sedation scale ≤4 or bispectral index values ≤80), 2) minimal additional sedation requirement (no more than two additional sedative administrations within the first 30 min), and 3) successful procedure completion (at least three EBUS-TBNA punctures).
RESULTS: A total of 84 patients (fentanyl group, 41; placebo group, 43) were enrolled. There were no significant differences in patient characteristics between the two groups. The primary outcome was significantly better in the fentanyl group than in the placebo group (46.3 % vs. 23.3 %, p = 0.038). A significantly lower rate of sedative-induced delirium, a lower number of additional sedative administrations, and a higher rate of ≥3 punctures were observed in the fentanyl group. There were no significant differences in complications. The operator visual analog scale questionnaire on cough, sputum, cooperation, and sedative effects was significantly better in the fentanyl group.
CONCLUSION: Adding fentanyl to midazolam provided better sedation. Midazolam combined with fentanyl should be considered during EBUS-TBNA.