Study Protocol of a Multicenter, Randomized, Single-Blind Trial: Efficacy and Safety of Remimazolam Tosylate for Sedation in ICU Patients

Funding

Sponsorship for this study and the journal’s Rapid Service and Open Access Fees will be funded by Jiangsu Hengrui Pharmaceuticals Co., Ltd. The funding body was not involved in the design of the study and will not participant in the collection, analysis and interpretation of research data or writing of the manuscript.

Authorship

All named authors in this article meet the International Committee of Medical Journal Editors (ICMJE) criteria and have given their approval for this version to be published.

Authors’ Contributions

The original draft of the manuscript was written by Ning Liu and Zhyi Jiang. Qin Liu performed the literature search, Ning Liu, Zhiyi Jiang, Yao Nie, Lingyun Zuo, Chuanxi Chen, Xiang Si, Minying Chen and Xiangdong Guan all contributed to the development and design of the protocol. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Disclosures

Qin Liu is an employee of Jiangsu Hengrui Pharmaceuticals Co., Ltd. Ning Liu, Zhiyi Jiang, Yao Nie, Lingyun Zuo, Chuanxi Chen, Xiang Si, Minying Chen and Xiangdong Guan declare that they have no competing interests

Compliance with Ethics Guidelines

This study is approved by The First Affiliated Hospital of Sun Yat-sen University clinical Research and Experimental Animal Ethics Committee (IEC) [IEC no. (2021)109] and ethics committees of all participating centers (for reference numbers for ethics committees of all participating hospitals, see Supplementary Material 2). The study will be performed in accordance with the Helsinki Declaration of 1964 and its later amendments; Written consent is required for all subjects and/or their guardian prior to the commencement of any procedures related to the study. There is no identifying information included in this manuscript.

Data Availability

Since no data sets were generated or analyzed in the current study, data sharing is not available.

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