Safety of remimazolam in deep sedation during flexible fiberoptic bronchoscopy: a prospective, randomized controlled trial
Abstract Background 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...
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BMC
2025-05-01
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| Online Access: | https://doi.org/10.1186/s12871-025-03117-8 |
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| author | Pingping Luo Jimin Wu Haiyan Lan Qiaomin Xu Gongchen Duan |
| author_facet | Pingping Luo Jimin Wu Haiyan Lan Qiaomin Xu Gongchen Duan |
| author_sort | Pingping Luo |
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| description | Abstract Background 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. Methods 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. Results 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 SpO2 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). Conclusions 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. Trial registration 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). |
| format | Article |
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| spelling | doaj-art-764d2ee3bc184ae3bf4de285da580fa52025-08-20T01:51:39ZengBMCBMC Anesthesiology1471-22532025-05-012511710.1186/s12871-025-03117-8Safety of remimazolam in deep sedation during flexible fiberoptic bronchoscopy: a prospective, randomized controlled trialPingping Luo0Jimin Wu1Haiyan Lan2Qiaomin Xu3Gongchen Duan4Department of Medical Oncology, Lishui People’s Hospital, The First Affiliated Hospital of Lishui University, Wenzhou Medical University Lishui HospitalDepartment of Anesthesiology, Lishui People’s Hospital, The First Affiliated Hospital of Lishui University, Wenzhou Medical University Lishui HospitalDepartment of Anesthesiology, Lishui People’s Hospital, The First Affiliated Hospital of Lishui University, Wenzhou Medical University Lishui HospitalDepartment of Anesthesiology, Lishui People’s Hospital, The First Affiliated Hospital of Lishui University, Wenzhou Medical University Lishui HospitalDepartment of Anesthesiology, Lishui People’s Hospital, The First Affiliated Hospital of Lishui University, Wenzhou Medical University Lishui HospitalAbstract Background 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. Methods 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. Results 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 SpO2 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). Conclusions 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. Trial registration 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).https://doi.org/10.1186/s12871-025-03117-8RemimazolamFlexible fiberoptic bronchoscopyDeep sedationElderly patients |
| spellingShingle | Pingping Luo Jimin Wu Haiyan Lan Qiaomin Xu Gongchen Duan Safety of remimazolam in deep sedation during flexible fiberoptic bronchoscopy: a prospective, randomized controlled trial BMC Anesthesiology Remimazolam Flexible fiberoptic bronchoscopy Deep sedation Elderly patients |
| title | Safety of remimazolam in deep sedation during flexible fiberoptic bronchoscopy: a prospective, randomized controlled trial |
| title_full | Safety of remimazolam in deep sedation during flexible fiberoptic bronchoscopy: a prospective, randomized controlled trial |
| title_fullStr | Safety of remimazolam in deep sedation during flexible fiberoptic bronchoscopy: a prospective, randomized controlled trial |
| title_full_unstemmed | Safety of remimazolam in deep sedation during flexible fiberoptic bronchoscopy: a prospective, randomized controlled trial |
| title_short | Safety of remimazolam in deep sedation during flexible fiberoptic bronchoscopy: a prospective, randomized controlled trial |
| title_sort | safety of remimazolam in deep sedation during flexible fiberoptic bronchoscopy a prospective randomized controlled trial |
| topic | Remimazolam Flexible fiberoptic bronchoscopy Deep sedation Elderly patients |
| url | https://doi.org/10.1186/s12871-025-03117-8 |
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