Effects of Remimazolam on Neurocognitive Function in Patients Undergoing Cardiovascular Surgery

May 13, 2026 updated by: SHI Jia, Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100037
        • State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College
        • Contact:
        • Principal Investigator:
          • Jia Shi, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Undergo elective cardiovascular surgery with cardiopulmonary bypass

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Remimazolam
General anesthesia is remimazolam-based, combined with other intravenous agents.
Control
General anesthesia is propofol-based, combined with other intravenous agents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the 5-day incidence of postoperative delirium
Time Frame: within five days postoperatively
the incedence of delirium evaluated by CAM/CAM-ICU
within five days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay (LOS) in intensive care unit (ICU)
Time Frame: Perioperative
Length of stay (LOS) in intensive care unit (ICU) postoperatively
Perioperative
Length of stay (LOS) in hospital
Time Frame: Perioperative
Length of stay (LOS) in hospital postoperatively
Perioperative
Time to extubation
Time Frame: Perioperative
Time to extubation postoperatively
Perioperative
the 30-day composite incidence of major adverse events
Time Frame: within 30 days postoperatively
Major adverse events refer to transient ischemic attack, stroke, renal insufficiency, myocardial infarction, pulmonary embolism, seizure and all-cause mortality.
within 30 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

November 20, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The EFFICACY study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe