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      Efficacy and safety of remimazolam in procedural sedation and analgesia : A protocol for systematic review and meta analysis

      review-article
      , MD, , MD, , MD, , MD, , MD, , MD, , MD, PhD
      Medicine
      Wolters Kluwer Health
      efficacy and safety, endoscopy, meta-analysis, midazolam, remimazolam

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          Abstract

          Background:

          Remimazolam is a newly developed benzodiazepine as an alternative of conventional sedatives in the procedure of anesthesia. For the purpose of evaluating the efficacy and safety of remimazolam sedation during an endoscopy, we will perform a systematic review and meta-analysis of randomized controlled trials that compared remimazolam with midazolam and/or placebo.

          Methods:

          We will search PubMed, Embase, Web of Science, and the Cochrane Controlled Register of Trials (CENTRAL) from inception to December 2019 for randomized controlled trials that investigated efficacy and safety of remimazolam during an endoscopy. The job will be performed without language restriction. Experimental groups will include the interventions of remimazolam, while control groups will involve midazolam, placebo, or no controls. The primary outcome will be the onset time, followed by the secondary outcomes of the recovery time, the incidence of hypotension, the incidence of hypoxia and the incidence of bradycardia. Relative ratio or standardized mean difference will be used to measure the effect size of remimazolam. We will use I 2 statistics to assess the between-study heterogeneity in each meta-analysis, Eager's test to detect publication bias.

          Results:

          The results of this study will be published in a peer-reviewed journal.

          Ethics and dissemination:

          There is no need for ethical approval because all data used in this meta-analysis have been published. In addition, all data will be analyzed anonymously during the review process.

          Protocol registration number:

          CRD42020170745.

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          Most cited references15

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          A placebo- and midazolam-controlled phase I single ascending-dose study evaluating the safety, pharmacokinetics, and pharmacodynamics of remimazolam (CNS 7056): Part I. Safety, efficacy, and basic pharmacokinetics.

          A new benzodiazepine, remimazolam, metabolized by tissue esterases to an inactive compound, CNS 7054, has been developed to permit a fast onset, a short and more predictable duration of sedative action, and a more rapid recovery profile than with currently available benzodiazepines. We report on the safety and efficacy of the first human study. A phase I, single-center, double-blind, placebo- and active-controlled, randomized, single-dose escalation study was conducted. Up to 10 cohorts of healthy subjects were scheduled to receive a single 1-minute IV infusion of remimazolam, midazolam, or placebo. In the 10 possible cohorts, remimazolam doses were from 0.01 to 0.35 mg/kg. In cohorts 1 to 3, 6 subjects received remimazolam and 1 placebo. From cohort 4 onward, an additional 3 subjects in each cohort received midazolam (0.075 mg/kg). Safety, pharmacokinetics, and pharmacodynamics were measured. A stop criterion of loss of consciousness for >5 minutes in >50% of subjects was predefined. The stop criterion was reached in cohort 9 (0.30 mg/kg remimazolam) so that 81 subjects were enrolled. Remimazolam was well tolerated in all dose cohorts, and no serious adverse events (AEs) were reported. Three AEs of mild (Spo(2) 85%-88%) hemoglobin desaturation (2 in the remimazolam groups and 1 in the midazolam group) resolved spontaneously, and 1 AE of moderate hemoglobin desaturation (Spo(2) 75%) resolved with a chin lift in the highest remimazolam dose group. No supplemental oxygen or manual ventilation was required. Vital signs remained stable throughout, although there was an increase in heart rate 2 minutes postdose for both remimazolam and midazolam. There were no reports of hypo- or hypertension. The pharmacokinetic behavior of remimazolam was linear and its systemic clearance approximately 3 times that of midazolam. Clearance was essentially independent of body weight. A rapid onset and dose-dependent sedation was observed after administration of remimazolam at 0.05 mg/kg and higher. Remimazolam (0.075 to 0.20 mg/kg) induced peak sedation levels similar to or higher than those achieved with midazolam (0.075 mg/kg). Median recovery times after approximately equieffective doses of remimazolam (0.10 and 0.15 mg/kg) and midazolam (0.075 mg/kg) were 10 and 40 minutes, respectively. Remimazolam provided sedation with rapid onset and offset, and was well tolerated. There was no supplemental oxygen or ventilation required. On the basis of these data, further studies on the potential utility of remimazolam for sedation/anesthesia are warranted.
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            Safety and Efficacy of Remimazolam Compared to Placebo and Midazolam for Moderate Sedation during Bronchoscopy

            While the complexity of flexible bronchoscopy has increased, standard options for moderate sedation medications have not changed in three decades. There is a need to improve moderate sedation while maintaining safety. Remimazolam was developed to address shortcomings of current sedation strategies.
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              A phase III study evaluating the efficacy and safety of remimazolam (CNS 7056) compared with placebo and midazolam in patients undergoing colonoscopy

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                Author and article information

                Journal
                Medicine (Baltimore)
                Medicine (Baltimore)
                MEDI
                Medicine
                Wolters Kluwer Health
                0025-7974
                1536-5964
                02 July 2020
                02 July 2020
                : 99
                : 27
                : e20765
                Affiliations
                Department of Anesthesiology, Affiliated Hospital of Guizhou Medical University, Gui yang, China.
                Author notes
                []Correspondence: Xiaohua Zou, Department of Anesthesiology, Affiliated Hospital of Guizhou Medical University, Gui yang, China, 9 Beijing road, Yunyan District, Guiyang City, Guizhou Province, China (e-mail: zouxhgy@ 123456163.com ).
                Author information
                http://orcid.org/0000-0002-4122-9122
                Article
                MD-D-20-04475 20765
                10.1097/MD.0000000000020765
                7337542
                32629656
                e5c73a12-20e3-4d61-87e9-6cf9048c201b
                Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc.

                This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0

                History
                : 17 May 2020
                : 20 May 2020
                Funding
                Funded by: Science and Technology Program of Guizhou Province
                Award ID: LH[2017]7204
                Award Recipient : Xiaohua Zou
                Categories
                3300
                Research Article
                Study Protocol Systematic Review
                Custom metadata
                TRUE

                efficacy and safety,endoscopy,meta-analysis,midazolam,remimazolam

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