Effects of Remimazolam on Neurocognitive Function in Patients Undergoing Cardiovascular Surgery

NCT07598019 | Not Yet Recruiting

• 1 other identifier: The EFFICACY study
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neurocognitive Disorder; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• the 5-day incidence of postoperative delirium

  the incedence of delirium evaluated by CAM/CAM-ICU

  within five days postoperatively

Secondary Outcomes (4)

• Time to extubation

  Perioperative

• Length of stay (LOS) in intensive care unit (ICU)

  Perioperative

• Length of stay (LOS) in hospital

  Perioperative

• the 30-day composite incidence of major adverse events

  within 30 days postoperatively

Study Arms (2)

Remimazolam

General anesthesia is remimazolam-based, combined with other intravenous agents.

Control

General anesthesia is propofol-based, combined with other intravenous agents.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Undergo elective cardiovascular surgery with cardiopulmonary bypass

You may qualify if:

• Male or female adult patients aged 60 years or older
• Receiving elective cardiovascular surgery with cardiopulmonary bypass
• Written Informed consent provided

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (1)

State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 Thoracic Surgeons (STS). Ann Thorac Surg. 2024 Apr;117(4):669-689. doi: 10.1016/j.athoracsur.2023.12.006. Epub 2024 Jan 28.

  PMID: 38284956 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Jia Shi, M.D.

CONTACT

+86 10 88322467; shijia@fuwai.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair, Department of Anesthesiology

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): November 20, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)