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Safety of remimazolam in deep sedation during flexible fiberoptic bronchoscopy: a prospective, randomized controlled
Pingping Luo1, Jimin Wu2, Haiyan Lan2
1Department 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.
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).
Insights
Remimazolam is safer than propofol for deep sedation during flexible fiberoptic bronchoscopy in elderly patients, showing fewer respiratory and cardiovascular issues. This study highlights remimazolam as a potentially superior sedative option for this patient group.
Area of Science:
- Anesthesiology
- Pulmonology
- Pharmacology
Background:
- Remimazolam is a novel, ultrashort-acting sedative and anesthetic.
- Its safety in deep sedation for flexible fiberoptic bronchoscopy (FFB) in elderly patients requires further investigation.
Purpose of the Study:
- To compare the safety and effectiveness of remimazolam versus propofol for deep sedation during FFB in elderly patients.
Main Methods:
- A randomized trial involving 66 elderly patients undergoing FFB.
- Patients were assigned to receive either remimazolam (Group R) or propofol (Group P) for deep sedation.
- The primary outcome was the incidence of hypoxemia during FFB.
Main Results:
- Remimazolam group showed significantly lower incidence of hypoxemia (9.1% vs. 45.5%) and hypotension (9.1% vs. 30.3%) compared to propofol.
- Higher minimum SpO2 and MAP, and lower changes in MAP and HR were observed in the remimazolam group.
- Incidence of injection pain was also lower with remimazolam (0% vs. 27.3%).
Conclusions:
- Remimazolam demonstrated superior safety compared to propofol for deep sedation in elderly patients undergoing FFB.
- It was associated with less respiratory depression and cardiovascular inhibition.
- Remimazolam presents a promising alternative for sedation in this specific patient population.
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