Effects of Remimazolam on Neurocognitive Function in Patients Undergoing Cardiovascular Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Neurocognitive Disorder, Cardiac Surgery. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Remimazolam on Neurocognitive Function in Patients Undergoing Cardiovascular Surgery (the EFFICACY Study)
Overview
The goal of this observational study is to explore the effect of remimazolam-based total intravenous anesthesia on postoperative neurocognitive function in patients who undergo cardiovascular surgery. The main question this study tries to answer is: Does remimazolam influence the incidence of postoperative delirium in cardiovascular surgery? Participants already apply remimazolam-based total intravenous anesthesia as part of their regular medical treatment for general anesthesia to perform cardiac surgery will answer questionnaires about cognitive function after surgery.
Primary outcome measures
- the 5-day incidence of postoperative delirium [Time frame: within five days postoperatively]
Secondary outcome measures (4)
- Time to extubation [Time frame: Perioperative]
- Length of stay (LOS) in intensive care unit (ICU) [Time frame: Perioperative]
- Length of stay (LOS) in hospital [Time frame: Perioperative]
- the 30-day composite incidence of major adverse events [Time frame: within 30 days postoperatively]
Eligibility criteria
Inclusion criteria
- Male or female adult patients aged 60 years or older
- Receiving elective cardiovascular surgery with cardiopulmonary bypass
- Written Informed consent provided
Exclusion criteria
- Deep hypothermia circulatory arrest
- Breastfeeding or pregnancy
- Mental or legal disability
- Terminal illness with a life expectancy of less than 3 months
- Unable to receive neuro-cognitive evaluation due to language, vision, or hearing impairments
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardio — Beijing
Publications
- American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults. Postoperative delirium in older adults: best practice statement from the American Geriatrics Society. J Am Coll Surg. 2015 Feb;220(2):136-48.e1. doi: 10.1016/j.jamcollsurg.2014.10.019. Epub 2014 Nov 14. No abstract available. PMID 25535170
- Sanson G, Khlopenyuk Y, Milocco S, Sartori M, Dreas L, Fabiani A. Delirium after cardiac surgery. Incidence, phenotypes, predisposing and precipitating risk factors, and effects. Heart Lung. 2018 Jul-Aug;47(4):408-417. doi: 10.1016/j.hrtlng.2018.04.005. Epub 2018 May 8. PMID 29751986
- Varsha AV, Unnikrishnan KP, Saravana Babu MS, Raman SP, Koshy T. Comparison of Propofol-Based Total Intravenous Anesthesia versus Volatile Anesthesia with Sevoflurane for Postoperative Delirium in Adult Coronary Artery Bypass Grafting Surgery: A Prospective Randomized Single-Blinded Study. J Cardiothorac Vasc Anesth. 2024 Sep;38(9):1932-1940. doi: 10.1053/j.jvca.2024.05.027. Epub 2024 May 23. PMID 38987101
- Grant MC, Crisafi C, Alvarez A, Arora RC, Brindle ME, Chatterjee S, Ender J, Fletcher N, Gregory AJ, Gunaydin S, Jahangiri M, Ljungqvist O, Lobdell KW, Morton V, Reddy VS, Salenger R, Sander M, Zarbock A, Engelman DT. Perioperative Care in Cardiac Surgery: A Joint Consensus Statement by the Enhanced Recovery After Surgery (ERAS) Cardiac Society, ERAS International Society, and The Society of Thora PMID 38284956
- Yu YR, Wang YL, Zhu XW, Li L, Wang DJ, Wang YP, Ye JX. Effect of dexmedetomidine on postoperative delirium in patients undergoing type A aortic dissection surgery: a prospective cohort study. J Thorac Dis. 2025 Jan 24;17(1):161-173. doi: 10.21037/jtd-24-1219. Epub 2025 Jan 22. PMID 39975717
- Shen J, Wang L, Liu Y, Li T, Zhu L, Li Z, Shi J, Lv H. Remimazolam besylate versus propofol as sedative agents in cardiac surgery: A randomized noninferiority clinical trial. Surgery. 2025 Nov;187:109661. doi: 10.1016/j.surg.2025.109661. Epub 2025 Sep 4. PMID 40912002
- Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28. PMID 23992774
- O'Neal JB, Shaw AD. Predicting, preventing, and identifying delirium after cardiac surgery. Perioper Med (Lond). 2016 Apr 26;5:7. doi: 10.1186/s13741-016-0032-5. eCollection 2016. PMID 27119013
Identifiers
NCT: NCT07598019 · The EFFICACY study