The Efficacy and Safety of Remimazolam Tosilate Versus Dexmedetomidine in Outpatients Undergoing Flexible Bronchoscopy: A Prospective, Randomized, Blind, Non-Inferiority Trial

Abstract

Purpose: This study aimed to compare the efficacy and safety of remimazolam tosilate-remifentanil (RT-RF) vs dexmedetomidine-remifentanil (Dex-RF) for outpatients undergoing fiberoptic bronchoscopy (FB).Patients and methods: We conducted a double-blind, randomized, prospective study involving a total of 146 outpatients undergoing FB divided into two groups. The RT-RF (RR) group (n = 73) received an initial dose of 12 mg/kg/h of RT for 10 min followed by a maintenance dose of 1–2 mg/kg/h, while the Dex-RF (DR) group (n = 73) received an initial dose of 0.5 μg/kg of Dex for 10 min followed by a maintenance dose of 0.2–0.7 μg/kg/h. All outpatients also received 0.05–0.2 μg/kg/min RF to maintain the Modified Observer’s Assessment of Alertness and Sedation (MOAA/S) scale <3. The primary outcome was rate of successful FB completed. Secondary outcomes were time metrics, hemodynamics, intubating conditions, oxygen saturation, coughing severity, number of remedies, total dose of fentanyl, RF, RT, and Dex, incidence of dreaming, patient and bronchoscopist satisfaction, willingness to repeat bronchoscopy, and adverse events.Results: The FB successful completion rate was 94.52% (95% CI: 89.20–99.90) in the RR group and 91.78% (95% CI: 85.30–98.20) in the DR group. Compared with patients in the DR group, the onset time, time to fully alert, and hospital discharge were all significantly shorter in the RR group (p < 0.01), and hemodynamics were more stable in the RR group. Intubating conditions, clinically acceptable intubating conditions, lowest oxygen saturation, coughing severity, consumption of fentanyl and RF, number of remedies, and patient and bronchoscopist satisfaction were similar between the groups (p > 0.05), as were demographic characteristics, incidence of dreaming, willingness to repeat bronchoscopy, and adverse events (p > 0.05).Conclusion: RT-RF has non-inferior efficacy, better time metrics and hemodynamic stability for outpatients undergoing FB than Dex-RF.Systematic Review Registration: [http://www.chictr.org.cn/showproj.aspx?proj=66673], identifier [ChiCTR2000041524].

Efficacy and safety of ciprofol-remifentanil versus propofol-remifentanil during fiberoptic bronchoscopy: A prospective, randomized, double-blind, non-inferiority trial

“…In addition, 25 µg of fentanyl was permitted once (maximum, 150 µg) until adequate analgesia could be achieved. The use of topical anesthetics during FB is referred to in our previous research ( Chen et al, 2022a ). In brief, 10 ml of 1% lidocaine was sprayed over the vocal cords, trachea, and right and left main bronchi to inhibit the patient’s cough reflex.…”

Remimazolam tosilate has a lower incidence of hypotension than propofol in painless colonoscopy

“…Meanwhile, mean arterial blood pressure reduced by 24 ± 6%, HR elevated by 28 ± 15%, and spontaneous breathing was maintained throughout the whole procedure [21]. Furthermore, some clinical studies proved that patients with remimazolam showed more stable hemodynamic effects, meanwhile, remimazolam slightly affected patients' respiration under the routine clinical sedative dose during their surgical procedures [20][21][22][23].…”

Profile of Remimazolam in Anesthesiology: A Narrative Review of Clinical Research Progress

“…Spontaneous resolution of the symptoms was observed. Comparatively, remimazolam is associated with a lower incidence of adverse events than midazolam and propofol, and the events tend to be mild, 52 as evidenced by a series of clinical trials. It is noted that during the application of remimazolam, patient blood pressure should be closely monitored, and vasoactive drugs can be prescribed if needed.…”