Anesthesia, Condition, Delirium
Conditions
Keywords
Postoperative cognitive function, Delirium, Cardiac Surgical Procedures, Precision cardiac anesthesia
Brief summary
This is a prospective, multi-center, double-blind, randomized clinical trials.
Detailed 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.
Interventions
PROCEDUREPrecision cardiac anesthesia
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.
PROCEDUREConventional cardiac anesthesia
The anesthesia strategy is mainly depending on the anesthesiologist's clinical experience
Sponsors
Tianjin Chest Hospital
The Second Hospital of Hebei Medical University
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of postoperative delirium | Postoperative day 1 to 5 | Delirium assessed by using Confusion Assessment Method-ICU (CAM-ICU) in the postoperative period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | Postoperative day 1 to 5, at 1,6 and 12 months after surgery | Assessed by NRS (from 0 to 10, higher scores mean a worse outcome) |
| CRP | Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery | Blood Biomarker (CRP) |
| S-100β protein | Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery | Blood Biomarker (S-100β protein) |
| Genotype | Before surgery | Number of participants with target gene |
| Postoperative cognitive function | In hospital,up to 10 days, at 1,6 and 12 months after surgery | 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) |
| Ventilation time | up to 1 month after surgery | Mechanical ventilation time after surgery |
| Length of stay | up to 2 months after surgery | Length of hospital and ICU stay |
| Cost | up to 2 months after surgery | health care costs of hospital and ICU |
| PONV | Postoperative day 1 to 5 | To quantify postoperative nausea and vomiting the following score was used: 0 = no nausea, 1 = nausea, 2 = retching, 3 = single vomiting, 4 = multiple vomiting. |
| IL-6, IL-8, IL-10 | Before surgery, 6h, postoperative day 1 (POD1) morning, 24h,after surgery | Inflammatory factor (IL-6, IL-8, IL-10) |
| TNF-α | Before surgery, 6h, postoperative day 1(POD1 )morning, 24h after surgery | Inflammatory factor (TNF-α) |
| IGF-1 | Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery | Blood Biomarker (IGF-1) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient's life quality | At 1,3 and 12 months after surgery | Quality of life was assessed by SF-36. A self-administered 36-item question- naire covering eight different domains: physical functioning, physical role functioning, bodily pain, general health, vitality, social functioning, emotional role functioning, and mental health. Raw points are transformed into a score from 0 to 100 for each dimension, with 100 reflecting the best possible health-related quality of life. |
| Rate of mortality | In hospital,up to 10 days, at 1,3 and 12 months after surgery | All-cause mortality |
| Rate of postoperative complications | In hospital,up to 10 days, at 1,3 and 12 months after surgery | Postoperative main complications |
Countries
China
Contacts
Primary ContactYuefu Wang, MD
Backup ContactYuchen Gao, MD
Outcome results
None listed