BMC anesthesiology · 2025
Feasibility and safety evaluation of remimazolam in geriatric patients during bronchoscopy: a single-centre randomized controlled trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Huang Yaqin, Yu Yang, Lei Weiping, Sun Jianliang
Аннотация
BACKGROUND: Fiberoptic bronchoscopy has developed rapidly as a routine test, especially it played an important role during the COVID-19. The suitable options for moderate sedation medications is necessary. The present study aimed to observation the feasibility and safety of remimazolam in geriatric patients undergoing fiberoptic bronchoscopy.
METHODS: This study is a single-center, randomized, parallel controlled trial conducted on patients undergoing fiberoptic bronchoscopy at the Hangzhou First People's Hospital, School of Medicine, Westlake University. A total of 105 geriatric patients undergoing fiberoptic bronchoscopy were divided into 3 groups (n=35) randomly. Group A (remimazolam + fentanyl + local anesthesia); Group B (midazolam + fentanyl + local anesthesia); Group C (local anesthesia).The primary outcomes include all patients' vital signs(Heart rate,non-invasive blood pressure,saturation of pulse oximetry,end-tidal carbon dioxide, bispectral index, respiratory rate), Modified Observer's Alertness/Sedatio and the rate of adverse events. Secondary outcomes are onset time of the drug, operation time , recovery time, operator and patient's satisfaction.
RESULTS: This study enrolled a total of 105 patients, among them 97 were actually included in the statistics(34 in group A, 30 in group B, and 33 in group C). Compared with group C, the vital signs in group A and B are more stable at T1, T2, T3, and T4 times(P<0.05), the frequency of hypertension in group A and group B was significantly lower (P<0.05). Compared with group B, the onset time and recovery time of group A were shortened (both P<0.05). The satisfaction levels of both patients and operators in group A and group B were higher than those in group C. (P<0.05).
CONCLUSIONS: In our study, we found that an intravenous injection of remimazolam at 0.2 mg/kg, combined with fentanyl at 0.5 μg/kg for sedation, along with local anesthesia of the pharynx and tracheal mucosa, and supplemental anesthesia with fentanyl 25 μg every 5 to 10 minutes if necessary, is effective and safe for geriatric patients during fiberoptic bronchoscopy.
TRIAL REGISTRATION: This study was registered with the Chinese clinical trial registry. ChiCTR2100047459,the Registration Date is 2021/06/19.
METHODS: This study is a single-center, randomized, parallel controlled trial conducted on patients undergoing fiberoptic bronchoscopy at the Hangzhou First People's Hospital, School of Medicine, Westlake University. A total of 105 geriatric patients undergoing fiberoptic bronchoscopy were divided into 3 groups (n=35) randomly. Group A (remimazolam + fentanyl + local anesthesia); Group B (midazolam + fentanyl + local anesthesia); Group C (local anesthesia).The primary outcomes include all patients' vital signs(Heart rate,non-invasive blood pressure,saturation of pulse oximetry,end-tidal carbon dioxide, bispectral index, respiratory rate), Modified Observer's Alertness/Sedatio and the rate of adverse events. Secondary outcomes are onset time of the drug, operation time , recovery time, operator and patient's satisfaction.
RESULTS: This study enrolled a total of 105 patients, among them 97 were actually included in the statistics(34 in group A, 30 in group B, and 33 in group C). Compared with group C, the vital signs in group A and B are more stable at T1, T2, T3, and T4 times(P<0.05), the frequency of hypertension in group A and group B was significantly lower (P<0.05). Compared with group B, the onset time and recovery time of group A were shortened (both P<0.05). The satisfaction levels of both patients and operators in group A and group B were higher than those in group C. (P<0.05).
CONCLUSIONS: In our study, we found that an intravenous injection of remimazolam at 0.2 mg/kg, combined with fentanyl at 0.5 μg/kg for sedation, along with local anesthesia of the pharynx and tracheal mucosa, and supplemental anesthesia with fentanyl 25 μg every 5 to 10 minutes if necessary, is effective and safe for geriatric patients during fiberoptic bronchoscopy.
TRIAL REGISTRATION: This study was registered with the Chinese clinical trial registry. ChiCTR2100047459,the Registration Date is 2021/06/19.