Neurocognitive DisorderNCT07598019
Effects of Remimazolam on Neurocognitive Function in Patients Undergoing Cardiovascular Surgery
An observational study of Neurocognitive Disorder and Cardiac Surgery, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Neurocognitive Disorder, Cardiac Surgery
- Type of treatment
- Injection or infusion
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2026to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Undergo elective cardiovascular surgery with cardiopulmonary bypass
Who may be able to join
- Male or female adult patients aged 60 years or older
- Receiving elective cardiovascular surgery with cardiopulmonary bypass
- Written Informed consent provided
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 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
Jia Shi, M.D., 86 10 88322467, shijia@fuwai.com
Jia Shi, M.D.
About this study
Official title: Effects of Remimazolam on Neurocognitive Function in Patients Undergoing Cardiovascular Surgery (the EFFICACY Study)
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
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam | General anesthesia is remimazolam-based, combined with other intravenous agents. | |
| Control | General anesthesia is propofol-based, combined with other intravenous agents. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the 5-day incidence of postoperative delirium
the incedence of delirium evaluated by CAM/CAM-ICU
Measured: within five days postoperatively
Secondary outcomes (4)
Time to extubation
Time to extubation postoperatively
Measured: Perioperative
Length of stay (LOS) in intensive care unit (ICU)
Length of stay (LOS) in intensive care unit (ICU) postoperatively
Measured: Perioperative
Length of stay (LOS) in hospital
Length of stay (LOS) in hospital postoperatively
Measured: Perioperative
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.
Measured: within 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start15 Jun 2026 (estimated)
- Primary completion20 Nov 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Neurocognitive DisorderStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHI Jia, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598019
- Sponsor's protocol ID
- The EFFICACY study
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 25535170Sanson 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 29751986Varsha 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 38987101Grant 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 38284956Yu 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 39975717Shen 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 40912002Inouye 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 23992774O'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
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Remimazolam on Neurocognitive Function in Patients Undergoing Cardiovascular Surgery (the EFFICACY Study)
- ClinicalTrials.gov ID
- NCT07598019
- Acronym / sponsor ID
- The EFFICACY study
- Conditions
- Neurocognitive Disorder, Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 20 Nov 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam | – | –General anesthesia is remimazolam-based, combined with other intravenous agents. |
| Control | – | –General anesthesia is propofol-based, combined with other intravenous agents. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Undergo elective cardiovascular surgery with cardiopulmonary bypass
Key inclusion criteria (3 listed)
- Male or female adult patients aged 60 years or older
- Receiving elective cardiovascular surgery with cardiopulmonary bypass
- Written Informed consent provided
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the 5-day incidence of postoperative delirium
Time frame: within five days postoperatively
the incedence of delirium evaluated by CAM/CAM-ICU
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Background: PubMed 25535170American 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.
- Background: PubMed 29751986Sanson 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.
- Background: PubMed 38987101Varsha 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.
- Background: PubMed 38284956Grant 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.
- Background: PubMed 39975717Yu 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.
- Background: PubMed 40912002Shen 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.
- Background: PubMed 23992774Inouye 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.
- Background: PubMed 27119013O'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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurocognitive Disorder and Cardiac Surgery, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia Shi, M.D. (+86 10 88322467, shijia@fuwai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the 5-day incidence of postoperative delirium (time frame: within five days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07598019, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.