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| Name | Class |
|---|---|
| Tianjin Chest Hospital | OTHER |
| The Second Hospital of Hebei Medical University | OTHER |
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This is a prospective, multi-center, double-blind, randomized clinical trials.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precision cardiac anesthesia | Experimental | Remifentanil (TCI) for intra-operative analgesia Propofol (TCI) for intra-operative sedation |
|
| Conventional cardiac anesthesia | Active Comparator | Institutional standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precision cardiac anesthesia | Procedure | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of postoperative complications | Postoperative main complications | In hospital,up to 10 days, at 1,3 and 12 months after surgery |
| Rate of mortality | All-cause mortality |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuefu Wang, MD | Contact | +(86)010-88396509 | wangyuefu@hotmail.com | |
| Yuchen Gao, MD | Contact | +(86)010-88392469 | gaoyuchen_pumc@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuefu Wang, MD | Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMC | Study Director |
| Jiange Han, MD | Tianjin Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of HeBei Medical University | Recruiting | Shijiazhuang | Hebei | 050000 | China |
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|
| Conventional cardiac anesthesia | Procedure | The anesthesia strategy is mainly depending on the anesthesiologist's clinical experience |
|
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 |
| In hospital,up to 10 days, at 1,3 and 12 months after surgery |
| Patient's life quality | 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. | At 1,3 and 12 months after surgery |
| Haitao Liu, MD |
| The Second Hospital of Hebei Medical University |
| Principal Investigator |
| Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMC | Recruiting | Beijing | 100037 | China |
|
| Tianjin Chest Hospital | Recruiting | Tianjin | 300222 | China |
|
| ID | Term |
|---|---|
| D003693 | Delirium |
| D004194 | Disease |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
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