Effects of Remimazolam on Neurocognitive Function in Patients Undergoing Cardiovascular Surgery

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07598019

Enrollment

210

Registered

2026-05-20

Start date

2026-06-15

Completion date

2027-12-30

Last updated

2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Neurocognitive Disorder

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

CONTACTJia Shi, M.D.

shijia@fuwai.com+86 10 88322467

Outcome results