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

Study Overview
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Brief Summary
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This is a prospective, multi-center, double-blind, randomized clinical trials.

Detailed Description
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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.

Official Title
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Effect of Different Anesthetic Strategies on Postoperative Cognitive Function and Delirium in Adult Patients Undergoing Cardiac Surgery

Conditions
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Delirium, Condition, Anesthesia

Intervention / Treatment
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* Procedure: Precision cardiac anesthesia
* Procedure: Conventional cardiac anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged≥18 years; ASA:I to III; Hemodynamic stability, LVEF≥40%; Cardiac surgery including CABG, valve surgery, CABG combined with valve surgery, surgical repair of ASD,VSD and atrial myxoma, and other types. Exclusion Criteria: Declined to get involved; Emergency cases, heart transplantation; Severe hepatic insufficiency (Child-Pugh grades C),Severe renal insufficiency (requirement of renal replacement therapy); Previous history of drug and alcohol abuse,allergy to general anesthetics; Preoperative severe dementia, language barrier and mental illness Preoperative schizophrenia, epilepsy, stroke and Parkinson's disease Previous history of craniocerebral injury or neurosurgery; Any other conditions that are considered unsuitable for study participation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Precision cardiac anesthesia<br>Remifentanil (TCI) for intra-operative analgesia Propofol (TCI) for intra-operative sedation | Procedure: Precision cardiac anesthesia<br>* Aperi-operative anesthetic management through target-controlled infusion to accurately control the patient blood concentration, with combination of bispectral index and neuromuscular monitoring to adjust the dosage of general anesthetics.<br>|
| Active Comparator: Conventional cardiac anesthesia<br>Institutional standard of care. | Procedure: Conventional cardiac anesthesia<br>* The anesthesia strategy is mainly depending on the anesthesiologist's clinical experience<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of postoperative delirium | Delirium assessed by using Confusion Assessment Method-ICU (CAM-ICU) in the postoperative period | Postoperative day 1 to 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative cognitive function | Assessed by MoCA (score range from 0 to 30, higher scores mean a better outcome) or MMSE (score range from 0 to 30, higher scores mean a better outcome) | In hospital,up to 10 days, at 1,6 and 12 months after surgery | 
| Ventilation time | Mechanical ventilation time after surgery | up to 1 month after surgery | 
| Length of stay | Length of hospital and ICU stay | up to 2 months after surgery | 
| Cost | health care costs of hospital and ICU | up to 2 months after surgery | 
| PONV | To quantify postoperative nausea and vomiting the following score was used: 0 = no nausea, 1 = nausea, 2 = retching, 3 = single vomiting, 4 = multiple vomiting. | Postoperative day 1 to 5 | 
| Postoperative pain | Assessed by NRS (from 0 to 10, higher scores mean a worse outcome) | Postoperative day 1 to 5, at 1,6 and 12 months after surgery | 
| IL-6, IL-8, IL-10 | Inflammatory factor (IL-6, IL-8, IL-10) | Before surgery, 6h, postoperative day 1 (POD1) morning, 24h,after surgery | 
| TNF-α | Inflammatory factor (TNF-α) | Before surgery, 6h, postoperative day 1(POD1 )morning, 24h after surgery | 
| IGF-1 | Blood Biomarker (IGF-1) | Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery | 
| CRP | Blood Biomarker (CRP) | Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery | 
| S-100β protein | Blood Biomarker (S-100β protein) | Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery | 
| Genotype | Number of participants with target gene | Before surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative cognitive function, Delirium, Cardiac Surgical Procedures, Precision cardiac anesthesia