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NCT Number: NCT07598019

Effects of Remimazolam on Neurocognitive Function in Patients Undergoing Cardiovascular Surgery

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.

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Key information

Conditions

Neurocognitive Disorder Cardiac Surgery Mental Disorders Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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 contact

Jia Shi, M.D.

CONTACT

[email protected]

86 10 88322467

Jia Shi, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. the 5-day incidence of postoperative delirium

    Time frame: within five days postoperatively

    the incedence of delirium evaluated by CAM/CAM-ICU

Secondary outcomes

  1. Time to extubation

    Time frame: Perioperative

    Time to extubation postoperatively

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

    Time frame: Perioperative

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

  3. Length of stay (LOS) in hospital

    Time frame: Perioperative

    Length of stay (LOS) in hospital postoperatively

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jia Shi, M.D.

CONTACT

[email protected]

+86 10 88322467

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

Effects of Remimazolam on Neurocognitive Function in Patients Undergoing Cardiovascular Surgery (the EFFICACY Study)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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