Different Anesthetic Strategies on Postoperative Cognitive Function and Delirium in Patients Undergoing Cardiac Surgery

National Center for Cardiovascular Diseases

Status: Unknown

Conditions: Delirium; Condition; Anesthesia

Treatments: Procedure: Conventional cardiac anesthesia; Procedure: Precision cardiac anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04505059

Precision-Delirium-Cognitive

Details and patient eligibility

About

This is a prospective, multi-center, double-blind, randomized clinical trials.

Full description

Prospective randomized multi-center trial involving about 502 subjects will be enrolled in 3 centers. Patients will be randomized to two groups in equal proportion. Investigators set a hypothesis that precision cardiac anesthesia, which involves the modification of several crucial anesthetic modalities, would reduces the incidence of postoperative cognitive function and delirium in patients undergoing cardiac surgery.

Enrollment: 502 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged≥18 years;
2. ASA:I to III;
3. Hemodynamic stability, LVEF≥40%;
4. Cardiac surgery including CABG, valve surgery, CABG combined with valve surgery, surgical repair of ASD,VSD and atrial myxoma, and other types.

Exclusion criteria

1. Declined to get involved;
2. Emergency cases, heart transplantation;
3. Severe hepatic insufficiency (Child-Pugh grades C),Severe renal insufficiency (requirement of renal replacement therapy);
4. Previous history of drug and alcohol abuse,allergy to general anesthetics;
5. Preoperative severe dementia, language barrier and mental illness
6. Preoperative schizophrenia, epilepsy, stroke and Parkinson's disease
7. Previous history of craniocerebral injury or neurosurgery;
8. Any other conditions that are considered unsuitable for study participation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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502 participants in 2 patient groups

Precision cardiac anesthesia

Experimental group

Description:

Remifentanil (TCI) for intra-operative analgesia Propofol (TCI) for intra-operative sedation

Treatment:

Procedure: Precision cardiac anesthesia

Conventional cardiac anesthesia

Active Comparator group

Description:

Institutional standard of care.

Treatment:

Procedure: Conventional cardiac anesthesia