Efficacy and Safety of Remimazolam Besylate Versus Propofol during Hysteroscopy: Single‐centre Randomized Controlled Trial

Zhang, Xiaoqiang; Li, Shuang; Liu, Jing

doi:10.21203/rs.3.rs-209379/v1

Cited by 12 publications

(24 citation statements)

References 23 publications

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“…The incidence of respiratory suppression in groups B and C was lower than that in group A, and there was no injection pain occurred in groups B and C. These indicated that the adverse events incidence of remimazolam tosylate was lower, especially in the low-dose remimazolam tosylate group. This result is consistent with the results of the study by Zhang et al 19 that remimazolam tosylate is a safer alternative to anaesthesia during hysteroscopy. On this basis, our study further investigated the recovery speed of remazolam and the better sedation and maintenance dose.…”

Section: Discussionsupporting

confidence: 93%

Efficacy and safety of remimazolam tosylate in hysteroscopy: A randomized, single‐blind, parallel controlled trial

Zhang

Wang

Ran

et al. 2021

Clinical Pharmacy Therapeu

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What is known and objective:To compare the effectiveness and safety of remimazolam tosylate and propofol for hysteroscopy.Methods: From November 2020 to June 2021, a total of 90 patients who underwent hysteroscopy were prospectively enrolled in this study. The patients were randomly assigned to three groups: propofol group (group A), low-dose remimazolam tosylate group (group B), and high-dose remimazolam tosylate group (group C), with 30 cases in each group. All cases received intravenous sufentanil 0.1ug/kg for analgesic preconditioning. Patients in group A were given 2 mg/kg propofol intravenously, and maintained at a rate of 5 mg/kg/h. Patients in groups B and C were given intravenous remimazolam tosylate 0.25 mg/kg. Group B was maintained with remimazolam tosylate at a rate of 0.48 mg/kg/h, while group C was at a rate of 0.6 mg/ kg/h. The changes of heart rate (HR), mean arterial pressure (MAP) and saturation of peripheral oxygen (SpO2) were recorded after admission (T0), 1 min after anaesthesia (T1), dilation of the uterine cavity (T2), and the end of hysteroscopy (T3). In addition, Observer's Assessment of Alertness/Sedation Scale (OAA/S) at 1 min, 3 min, and 5 min after hysteroscopy, the incidence of adverse events, and the time from the end of the hysteroscopy to reach the discharge standard, were recorded. Results and discussion:The success rate of sedation in each group was 100%. After administration, the adverse event incidence in group A was significantly higher than that in groups B and C (p < 0.05, respectively). Compared with propofol, remimazolam tosylate did not cause injection pain, had less impact on haemodynamics and caused less respiratory depression.What is new and conclusion: Remimazolam tosylate and propofol have similar success rates for painless hysteroscopy, and both can provide safe and effective sedation. The safety of remimazolam tosylate for hysteroscopy appears to be better than that of propofol.

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Section: Discussionsupporting

confidence: 93%

Efficacy and safety of remimazolam tosylate in hysteroscopy: A randomized, single‐blind, parallel controlled trial

Zhang

Wang

Ran

et al. 2021

Clinical Pharmacy Therapeu

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“…When compared with propofol in both sedation and general anesthesia, remimazolam exhibited better safety profile, including a lower incidence of hypotension, less bradycardia treatment requirement, and no pain on injection [34,36,41]. However, propofol was less likely to develop PONV.…”

Section: Safety Concerns and Future Directionsmentioning

confidence: 99%

“…Therefore, there is a need for safer sedatives while ensuring their efficacy [35]. Clinical studies comparing efficacy and safety of remimazolam vs. propofol for procedural sedation suggested that remimazolam was non-inferior in terms of sedative efficacy and exhibited better safety profile than that of propofol [32,34,36]. Chen et al [32] demonstrated that the procedure success rate in the remimazolam group was similar to that in the propofol group (96.91% vs. 100%, respectively) in 384 patients who underwent colonoscopy [32].…”

Section: Clinical Applications Of Remimazolam Remimazolam For Procedural Sedationmentioning

confidence: 99%

Remimazolam: pharmacological characteristics and clinical applications in anesthesiology

Kim

2022

Anesth Pain Med

130

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A novel ultra-short-acting benzodiazepine (BDZ), remimazolam (CNS 7056), has been designed by ‘soft drug’ development to achieve a better sedative profile than that of the current drugs. Notably, the esterase linkage in remimazolam permits rapid hydrolysis to inactivate metabolites by non-specific tissue esterase and induces a unique and favorable pharmacological profile, including rapid onset and offset of sedation and a predictable duration of action. Similar to other BDZs, its sedative effects can be reversed using flumazenil, a BDZ antagonist. The pharmacokinetics and pharmacodynamics of remimazolam are characterized by relatively high clearance, small steady-state volume of distribution, short elimination half-life, short context-sensitive half-life, and fast onset and recovery, indicating rapid elimination, minimal tissue accumulation, and good control. In addition, remimazolam possesses a superior safety profile, including low liability for cardiorespiratory depression and injection pain, making it a preferred hypnotic agent in various clinical settings. Early clinical investigations suggest that remimazolam is well tolerated and effective for procedural sedation and for induction and maintenance of general anesthesia. To date, however, the clinical use of remimazolam has been confined to a few volunteer studies and a limited number of clinical investigations. Therefore, further studies regarding its recovery issues or postoperative complications, characteristics of electroencephalogram changes, and cost-benefit analyses are required to facilitate its widespread use.

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“…Three phase II studies of remimazolam besylate in procedural sedation have been published. The first was in 100 patients undergoing upper gastrointestinal endoscopy ( Borkett et al, 2015 ), the second in 162 patients undergoing colonoscopy ( Pambianco et al, 2016 ), and the third in 82 patients undergoing hysteroscopy ( Zhang et al, 2021 ). A midazolam-treated group was included as a comparator in the first two studies.…”

Section: Remimazolammentioning

confidence: 99%

“…In high-risk patients (ASA class III/IV), a safety profile similar to that in low-risk patients was observed ( Rex et al, 2021 ). Compared with propofol in procedural sedation, remimazolam showed a lower incidence of hypotension, respiratory depression, and injection site pain ( Chen et al, 2020a ; Chen et al, 2021 ; Zhang et al, 2021 ).…”

Section: Remimazolammentioning

confidence: 99%

Remimazolam: Non-Clinical and Clinical Profile of a New Sedative/Anesthetic Agent

Kilpatrick¹

2021

Front. Pharmacol.

143

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A program to identify novel intravenous sedatives with a short and predictable duration of action was initiated in the late 1990’s by Glaxo Wellcome. The program focussed on the identification of ester-based benzodiazepine derivatives that are rapidly broken down by esterases. Remimazolam was identified as one of the lead compounds. The project at Glaxo was shelved for strategic reasons at the late lead optimization stage. Via the GSK ventures initiative, the program was acquired by the small biotechnology company, TheraSci, and, through successive acquisitions, developed as the besylate salt at CeNeS and PAION. The development of remimazolam besylate has been slow by industry standards, primarily because of the resource limitations of these small companies. It has, however, recently been approved for anesthesia in Japan and South Korea, procedural sedation in the United States, China, and Europe, and for compassionate use in intensive care unit sedation in Belgium. A second development program of remimazolam was later initiated in China, using a slightly different salt form, remimazolam tosylate. This salt form of the compound has also recently been approved for procedural sedation in China. Remimazolam has the pharmacological profile of a classical benzodiazepine, such as midazolam, but is differentiated from other intravenous benzodiazepines by its rapid conversion to an inactive metabolite resulting in a short onset/offset profile. It is differentiated from other intravenous hypnotic agents, such as propofol, by its low liability for cardiovascular depression, respiratory depression, and injection pain. The benzodiazepine antagonist flumazenil can reverse the effects of remimazolam in case of adverse events and further shorten recovery times. The aim of this review is to provide an analysis of, and perspective on, published non-clinical and clinical information on 1) the pharmacology, metabolism, pharmacokinetics, and pharmacodynamic profile of remimazolam, 2) the profile of remimazolam compared with established agents, 3) gaps in the current understanding of remimazolam, 4) the compound’s discovery and development process and 5) likely future developments in the clinical use of remimazolam.

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Efficacy and Safety of Remimazolam Besylate Versus Propofol during Hysteroscopy: Single‐centre Randomized Controlled Trial

Cited by 12 publications

References 23 publications

Efficacy and safety of remimazolam tosylate in hysteroscopy: A randomized, single‐blind, parallel controlled trial

Efficacy and safety of remimazolam tosylate in hysteroscopy: A randomized, single‐blind, parallel controlled trial

Remimazolam: pharmacological characteristics and clinical applications in anesthesiology

Remimazolam: Non-Clinical and Clinical Profile of a New Sedative/Anesthetic Agent

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