Jiang, Linghui
Wang, Jie
Chen, Wannan
Wang, Zhiyao
Xiong, Wanxia
Funding for this research was provided by:
National Natural Science Foundation of China (81901130)
Article History
Received: 15 May 2023
Accepted: 24 February 2024
First Online: 12 March 2024
Declarations
:
: The Ethics Committee of the Zhongshan Hospital, Fudan University, approved the third version of the revised protocol on August 26, 2022 (Approval No.: B2020-314(3)), which will be conducted according to the principles of the Declaration of Helsinki (64th WMA General Assembly, Fortaleza, Brazil, October 2013) and in accordance with the Medical Research Involving Human Subjects Act. The study is registered with the Clinical Trial Register (No. ChiCTR2000040252). Study results will be published in peer-reviewed journals. Written informed consent will be sought from individuals enrolled on the study. No potential risks will arise from conducting the research because there is no intervention. However, possible adverse reactions, including cognitive dysfunction, postoperative agitation, and postoperative pain might occur after each anesthesia and surgery. When an adverse event occurs during the study, the time of occurrence, clinical manifestations, treatment process, duration, and event outcomes will be recorded in detail on case report forms. Severe adverse events will be reported to the sponsor, the Ethics Committee, the Health Administration Department, and the National Medical Products Administration within 24 h.
: Not applicable.
: The authors declare no competing interests.