Luo Pingping, Wu Jimin, Lan Haiyan, Xu Qiaomin, Duan Gongchen
Department of Medical Oncology, Lishui People's Hospital, The First Affiliated Hospital of Lishui University, Wenzhou Medical University Lishui Hospital, Lishui, People's Republic of China.
Department of Anesthesiology, Lishui People's Hospital, The First Affiliated Hospital of Lishui University, Wenzhou Medical University Lishui Hospital, No. 1188, Liyang Street, Lishui, 323000, Zhejiang, People's Republic of China.
BMC Anesthesiol. 2025 May 15;25(1):246. doi: 10.1186/s12871-025-03117-8.
Remimazolam is a novel ultrashort-acting sedative and anesthetic drug. Numerous recent studies have demonstrated its sedative effect, however, research has yet to be conducted to explore the safety of remimazolam in deep sedation flexible fiberoptic bronchoscopy (FFB) in elderly patients.
Sixty-six elderly patients who underwent FFB were randomly assigned to either the remimazolam (Group R) or propofol (Group P) group. Initially, both groups received an intravenous injection of 10 µg/kg alfentanil. Subsequently, both groups were administered experimental drugs intravenously: (1) Group R received 0.2 mg/kg remimazolam, and (2) Group P received 1.5 mg/kg propofol. Throughout the FFB, patients were maintained in a state of deep sedation (modified observer's assessment of alertness/sedation score ≤ 1) by titrating the experimental drugs as needed. The primary outcome measured was the incidence of hypoxemia during the FFB. Secondary outcomes included other safety outcomes, effectiveness outcomes, and procedural characteristics.
Group R had a lower incidence of hypoxemia compared to Group P (9.1% vs. 45.5%) (RR, 0.20 [95% CI, 0.06-0.63], P = 0.001). The Minimum SpO and minimum MAP in Group R was higher than in Group P (93.1 ± 3.8 vs. 89.0 ± 6.7, P = 0.004) (82.8 ± 12.4 vs. 72.8 ± 14.1, P = 0.003); ΔMAP and ΔHR in Group R was lower than in Group P (15.9 ± 5.2 vs. 28.8 ± 12.4, P < 0.001), (14.9 ± 3.2 vs. 17.8 ± 4.2, P = 0.003); the incidence of hypotension in Group R was lower than in Group P (9.1% vs. 30.3%, P = 0.030); the incidence of injection pain in Group R was lower than in Group P (0% vs. 27.3%, P = 0.001).
During the maintenance of elderly patients under deep sedation with FFB, remimazolam exhibited superior safety than propofol, particularly in terms of respiratory depression and cardiovascular inhibition.
The trial was registered, before patient enrollment, in the Chinese Clinical Trial Registry ( www.chictr.org.cn ) (clinical trial number: ChiCTR2400083383; Principal Investigator: Gongchen Duan; date of registration: 23 April 2024).
瑞马唑仑是一种新型超短效镇静麻醉药物。近期众多研究证实了其镇静作用，但尚未有研究探讨瑞马唑仑在老年患者深度镇静可弯曲纤维支气管镜检查（FFB）中的安全性。
66例行FFB的老年患者被随机分为瑞马唑仑组（R组）和丙泊酚组（P组）。两组患者均先静脉注射10 μg/kg阿芬太尼。随后，两组患者静脉给予试验药物：（1）R组给予0.2 mg/kg瑞马唑仑，（2）P组给予1.5 mg/kg丙泊酚。在整个FFB过程中，根据需要滴定试验药物，使患者维持在深度镇静状态（改良的观察者警觉/镇静评分≤1）。主要观察指标为FFB过程中低氧血症的发生率。次要观察指标包括其他安全性指标、有效性指标和操作特征。
R组低氧血症发生率低于P组（9.1%对45.5%）（RR，0.20[95%CI，0.06 - 0.63]，P = 0.001）。R组的最低SpO₂和最低平均动脉压（MAP）高于P组（93.1±3.8对89.0±6.7，P = 0.004）（82.8±12.4对72.8±14.1，P = 0.003）；R组的MAP变化量（ΔMAP）和心率变化量（ΔHR）低于P组（15.9±5.2对28.8±12.4，P < 0.001），（14.9±3.2对17.8±4.2，P = 0.003）；R组低血压发生率低于P组（9.1%对30.3%，P = 0.030）；R组注射痛发生率低于P组（0%对27.3%，P = 0.001）。
在老年患者FFB深度镇静维持过程中，瑞马唑仑的安全性优于丙泊酚，尤其是在呼吸抑制和心血管抑制方面。
该试验在患者入组前在中国临床试验注册中心（www.chictr.org.cn）注册（临床试验注册号：ChiCTR2400083383；主要研究者：段功晨；注册日期：2024年4月23日）。
