Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2023
Comparison of Remimazolam and Propofol for Drug-Induced Sleep Endoscopy: A Randomized Clinical Trial.
Рандомизированное исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Zhang Jianxi, Zhang Yiying, Fang Xing, Weng Lili, Zhu Sha, Luo Ning, Huang Donghai, Guo Qulian, Huang Changsheng
Аннотация
OBJECTIVE: To compare the efficacy and safety of remimazolam with those of propofol for drug-induced sleep endoscopy (DISE) in patients with obstructive sleep apnea-hypopnea syndrome (OSAHS).
STUDY DESIGN: A prospective, single-center, randomized clinical trial.
SETTING: Xiangya Hospital of Central South University.
METHODS: Patients with OSAHS receiving DISE were randomly assigned to either the remimazolam or propofol group. The primary outcome was the incidence of hypoxemia (pulse oxygen saturation [SpO2 ] < 90%) during DISE. The secondary outcomes were the incidence of severe hypoxemia (SpO2 < 80%), the minimal value of SpO2 , sedation success rate (completion of DISE according to the medication regimen), and incidence of events of interest (including injection pain, bradycardia, and decreased respiratory rate).
RESULTS: Sixty-four patients were included in this study. The incidence of hypoxemia was significantly lower in the remimazolam than in the propofol group (25.00% vs 62.50%, respectively; relative risk, 0.40; 95% confidence interval [CI], 0.20-0.74; p < .01). There was no significant difference in the sedation success rate between the remimazolam and propofol groups (96.88% vs 81.25%, respectively; relative risk, 1.19; 95% CI, 1.01-1.50; p = .10). The incidence of at least 1 event of interest was lower in the remimazolam than in the propofol group (43.75% vs 96.88%, respectively; relative risk, 0.45; 95% CI, 0.29-0.63; p < .01).
CONCLUSION: Remimazolam can present satisfactory sedative efficacy in DISE, with a lower incidence of hypoxemia and a higher safety profile than propofol.
STUDY DESIGN: A prospective, single-center, randomized clinical trial.
SETTING: Xiangya Hospital of Central South University.
METHODS: Patients with OSAHS receiving DISE were randomly assigned to either the remimazolam or propofol group. The primary outcome was the incidence of hypoxemia (pulse oxygen saturation [SpO2 ] < 90%) during DISE. The secondary outcomes were the incidence of severe hypoxemia (SpO2 < 80%), the minimal value of SpO2 , sedation success rate (completion of DISE according to the medication regimen), and incidence of events of interest (including injection pain, bradycardia, and decreased respiratory rate).
RESULTS: Sixty-four patients were included in this study. The incidence of hypoxemia was significantly lower in the remimazolam than in the propofol group (25.00% vs 62.50%, respectively; relative risk, 0.40; 95% confidence interval [CI], 0.20-0.74; p < .01). There was no significant difference in the sedation success rate between the remimazolam and propofol groups (96.88% vs 81.25%, respectively; relative risk, 1.19; 95% CI, 1.01-1.50; p = .10). The incidence of at least 1 event of interest was lower in the remimazolam than in the propofol group (43.75% vs 96.88%, respectively; relative risk, 0.45; 95% CI, 0.29-0.63; p < .01).
CONCLUSION: Remimazolam can present satisfactory sedative efficacy in DISE, with a lower incidence of hypoxemia and a higher safety profile than propofol.