ClinicalTrials.gg
Not yet recruitingNCT07598019Updated May 20, 2026

Effects of Remimazolam on Neurocognitive Function in Patients Undergoing Cardiovascular Surgery

An observational study in Neurocognitive Disorder and Cardiac Surgery, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Not yet recruiting at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-05-20.

Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
210
Ages
60 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 21 studies in Neurocognitive Disorders with a site in China — 12 open to participants now, 13 under way, 1 of them phase 3. Neurocognitive Disorders · China.

Started
2026
with 4 others
Observational
6 of 21
4 open now
Primary completion
2027-11
later than 7 of 12 live
Registered
18th of 21
by date
Lead sponsor
3 of 21
Chinese Academy of Medical Sciences, Fuwai Hospital

Among the 21 studies in Neurocognitive Disorders with a site in China, this one is one of 5 that started in 2026, is one of 6 observational ones, reaches primary completion later than 7 of the 12 other live ones, and was the 18th registered.

Neurocognitive Disorders

274 studies on the registry are indexed under Neurocognitive Disorders; 90 are open to participants now.

This study's planned enrollment of 210 is above the median of 150 across 96 observational studies indexed under Neurocognitive Disorders.

Browse Neurocognitive Disorders studies →

Open to participants now

12 of the 21 studies in Neurocognitive Disorders with a site in China are open now.

All 12 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 59 Neurocognitive Disorders studies recruiting now, 36 (61%) set no upper age limit and 2 (3%) stop at 75 or younger; 4 take children under 18; 17 take healthy volunteers.

This study: 60 Years and older · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 21 studies in Neurocognitive Disorders with a site in China, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Neurocognitive Disorder
  • Cardiac Surgery
04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Undergo elective cardiovascular surgery with cardiopulmonary bypass

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female adult patients aged 60 years or older
  2. Receiving elective cardiovascular surgery with cardiopulmonary bypass
  3. Written provided

Exclusion criteria

Exclusion Criteria:

  1. Deep hypothermia circulatory arrest
  2. Breastfeeding or pregnancy
  3. Mental or legal disability
  4. Terminal illness with a of less than 3 months
  5. Unable to receive neuro-cognitive evaluation due to language, vision, or hearing impairments
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
210 participants (estimated)
Patient registry
No

Groups and cohorts

  • Remimazolam

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

  • Control

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

06

What researchers measure

Primary outcomes

  1. the 5-day incidence of postoperative delirium

    the incedence of delirium evaluated by CAM/CAM-ICU

    Time frame: within five days postoperatively

Secondary outcomes

  1. Time to extubation

    Time to extubation postoperatively

    Time frame: Perioperative

  2. Length of stay (LOS) in intensive care unit (ICU)

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

    Time frame: Perioperative

  3. Length of stay (LOS) in hospital

    Length of stay (LOS) in hospital postoperatively

    Time frame: Perioperative

  4. the 30-day composite incidence of major adverse events

    Major adverse events refer to transient ischemic attack, stroke, renal insufficiency, myocardial infarction, pulmonary embolism, seizure and all-cause mortality.

    Time frame: within 30 days postoperatively

07

Study locations

1 site
  • 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
    • Jia Shi, M.D. · Contactshijia@fuwai.com · 86 10 88322467
    • Jia Shi, M.D. · Principal investigator
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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 Thoracic Surgeons (STS). Ann Thorac Surg. 2024 Apr;117(4):669-689. doi: 10.1016/j.athoracsur.2023.12.006. Epub 2024 Jan 28. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 27119013 ↗

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be shared in order to protect participant privacy and confidentiality. Additionally, the consent obtained from participants does not include provisions for data sharing, in accordance with ethical guidelines and institutional policies.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2026; primary completion for Nov 2027, 17 months later.

Of 52 non-industry observational studies under Neurocognitive Disorders, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 78. This study's planned 17 months is below that.

Counting every sponsor, half of 53 studies reached it within 44 months; a quarter within 20 and three quarters within 78.

How these figures are worked out, and which studies are left out of them.

Registered
May 13, 2026
First posted
May 20, 2026
StartEst.
Jun 15, 2026
Primary completionEst.
Nov 20, 2027
CompletionEst.
Dec 30, 2027
Last update
May 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07598019
Responsible party
SHI Jia (Vice Chair, Department of Anesthesiology, Chinese Academy of Medical Sciences, Fuwai Hospital) — Principal investigator
First posted
May 20, 2026
Start date
Jun 15, 2026 (estimated)
Primary completion
Nov 20, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
May 20, 2026

Study contacts

Jia Shi, M.D.
Contact
shijia@fuwai.com
+86 10 88322467

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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