The Availability and Safety Study of Remimazolam Besylate for Injection on Sedation of ERAS Patients Under Mechanical Ventilation in ICU: Protocol for a Randomized, Open-Label, Controlled Trial

• DOI: 10.3389/fmed.2021.735473
• Publication Date: 2021-11-05T16:23:31Z
• Authors: Shengjun Liu; Longxiang Su; Bo Zhang; Huaiwu He; Zunzhu Li; Qi Li; Qianlin Wang; Fang Smith; Yun Long
• Keywords: Medicine (General); 03 medical and health sciences; R5-920; 0302 clinical medicine; sedation; Remimazolam Besylate; Medicine; ERAS; mechanical ventilation; intensive care unit; 3. Good health

Introduction: The most common physiological and psychological disorders associated with critical care patients are pain anxiety. Sedatives analgesics commonly used to relieve these symptoms. However, the adverse effects of sedatives inevitable. As a new type sedative drug, limited number trials available evaluate Remimazolam Besylate's availability safety compared propofol. Methods: This study is single center, randomized, open-label, controlled trial. A total 84 who meet ERAS criteria receive mechanical ventilation in ICU, aged ≥18 years old will be included. Patients randomized (1:1) into two groups: Besylate group Propofol group. Primary outcomes includes satisfaction rate sedation incidence major clinical events. Secondary including delirium, time weaning extubation, Difficulty nursing RASS, BIS PI, 28-days survival, side-effect vital signs during medications, dose per kilogram body weight analgesic rescue therapy experimental Ethics Dissemination: trial has been approved by ethics boards Peking Union Medical College Hospital. Recruitment began January 2022 continue until June 2022. Dissemination plans include presentations at scientific conferences, publications, stakeholder engagement efforts presentation public via lay media outlets. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT04947345.