Administrative information
Title {1} | Efficacy and safety of remimazolam for non-obese patients during anesthetic induction in cardiac surgery: study protocol for a multicenter randomized trial |
Trial registration {2a and 2b} | Chinese Clinical Trial Registry ID: ChiCTR2100050122, August 16, 2021 |
Protocol version {3} | October 2020, version 1.1 |
F unding {4} | None |
Author details {5a} | Hong Yu, MD Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu 610041, China. happyjia1990@foxmail.com Hong-Mei Liu, MSc Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu 610041, China. 18102429203@163.com Ping Li, MSc Department of Anesthesiology, Wu’an First People’s Hospital, Wu’an 056300, China. 595950583@qq.com Hai Yu, MD Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu 610041, China. yuhai@scu.edu.cn Bin Liu, MD Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu 610041, China. liubinhxyy@163.com. Corresponding author Peng Liang, MD Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu 610041. Day Surgery Center, West China Hospital, Sichuan University, Chengdu 610041, China. liangpeng_world@foxmail.com. Corresponding author |
Name and contact information for the trial sponsor {5b} | The trial sponsor is the West China Hospital of Sichuan University, Chengdu, China. Postal address: No.37 Guoxue Alley, Chengdu 610041, Sichuan, China. Tel: + 862885423592, Fax: 86–28-85423593 |
Role of sponsor {5c} | The trial sponsor has a regulatory role and will play a part in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods
Study setting {9}
Eligibility criteria {10}
Inclusion criteria
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Study drug administration
Anesthesia and CPB management
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Primary outcome
Secondary outcomes
Participant timeline {13}
Study period | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
Enrollment | Allocation | Intervention | Post-intervention | |||||||
Time point | Preoperative visit | Allocation | During induction until 20 min after induction | POD1 | POD2 | POD3 | POD4 | POD5 | POD6 | POD7 |
Enrollment | ||||||||||
Eligibility screen | × | |||||||||
Informed consent | × | |||||||||
Demographic date | × | |||||||||
Allocation | × | |||||||||
Interventions | ||||||||||
Midazolam | × | |||||||||
Etomidate | × | |||||||||
Remimazolam | × | |||||||||
Surgery and anesthesia date | × | |||||||||
Assessments | × | |||||||||
BIS | × | |||||||||
SBP/DBP/MBP HR/CVP/CO/SVR | × | |||||||||
RASS | × | × | × | × | × | × | × | × | ||
CAM-ICU | × | × | × | × | × | × | × | × |