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Effects of Remimazolam on Neurocognitive Function in Patients Undergoing Cardiovascular Surgery

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Chinese Academy of Medical Sciences, Fuwai Hospital

Status

Begins enrollment this month

Conditions

Cardiac Surgery
Neurocognitive Disorder

Study type

Observational

Funder types

Other

Identifiers

NCT07598019
The EFFICACY study

Details and patient eligibility

About

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.

Enrollment

210 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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

Trial design

210 participants in 2 patient groups

Remimazolam
Description:
General anesthesia is remimazolam-based, combined with other intravenous agents.
Control
Description:
General anesthesia is propofol-based, combined with other intravenous agents.

Trial contacts and locations

1

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Central trial contact

Jia Shi, M.D.

Data sourced from clinicaltrials.gov

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