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Post-Operative Cognition Dysfunction (POCD) is a common complication after surgery, POCD can lead to a reduced ability and seriously affect the quality of life of patients, increase personal and social burden, POCD may also increase mortality.POCD can occur at any age, but the long-term, affect the daily lives of POCD in elderly patients over 60 years of age are more prone. Age is a risk factor for advanced or long-term POCD. POCD determined by preoperative cognitive function and psychological scales postoperative assessment, the main recommendation of the agreed test methods include, Rey auditory verbal test, the connection test, digit span test. In this study, preoperative mini-mental state examination (MMSE) screening, comprehensive neurological function during hospitalization for memory, attention, executive function and exercise capacity test, and telephone follow-up after discharge Scale Revised (TICS-M) test.
Few study showed that dexmedetomidine may improve cognitive function in young patients others show that dexmedetomidine did not reduce POCD incidence after 24 hours of surgery. These results conflict and it is necessary to carry out large-scale, multi-center, randomized, controlled clinical study to determine whether dexmedetomidine reduce the POCD incidence or not for elderly patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Experimental | 0.5μg/kg Dexmedetomidine as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/h and stopped 30 minutes before the surgery over. |
|
| Controlled | Placebo Comparator | 0.5μg/kg Saline as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/h and stopped 30 minutes before the surgery over. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 0.5μg/kg Dexmedetomidine as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/min and stopped 30 minutes before the surgery over. |
| Measure | Description | Time Frame |
|---|---|---|
| The change of incidence of postoperative cognition dysfunction |
| 1 day Before surgery,the 3rd,7th day after the surgery. |
| The change of incidence of postoperative delirium | Through CAM-ICU to assess the incidence of the postoperative delirium. | The first, second and third day after the surgery. |
| The change of Neuropsychological status | Through the Telephone Interview for Cognitive Status-Modified(TICS-m) to follow up. | the 3rd,6th month after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of cardiovascular events. | from begging of the anesthesia to the time the patients discharge, up to 1 month. | |
| The incidence of any adverse or severe adverse events. | Including kidney or brain related adverse events. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Er Gu | The First Affiliated Hospital of Anhui Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anqing Municipal Hospital | Anqing | Anhui | China | |||
| Affiliated Hospital of Bengbu Medical College |
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|
| Saline | Drug | 0.5μg/kg saline as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/min and stopped 30 minutes before the surgery over. |
|
| From the beginning of the admitted to 6 month after the surgery, up to 6 month. |
| The variation of heart rate. | Heart rate is recorded every 15 minutes during the anesthesia. | From the beginning to the end of anesthesia,up to 6 hours. |
| The variation of blood pressure. | blood pressure is recorded every 15 minutes during the anesthesia. | From the beginning to the end of anesthesia,up to 6 hours. |
| the variation of pulse oxygen saturation. | Pulse oxygen saturation is recorded every 15 minutes during the anesthesia. | From the beginning to the end of anesthesia,up to 6 hours. |
| The monitor of depth of anesthesia. | Bispectral index (Bis) is recorded every 15 minutes during the anesthesia. | From the beginning to the end of anesthesia,up to 6 hours. |
| The serum concentrations of BDNF | Serum level of brain-derived neurotrophic factor (BDNF) was measured | From the baseline to the 3-day,7-day and 1-month. |
| Bengbu |
| Anhui |
| China |
| Affiliated Chaohu Hospital of Anhui Medical Hospital | Chaohu | Anhui | China |
| Binhu Hospital of Hefei | Hefei | Anhui | China |
| Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui | China |
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | China |
| The first Hospital of Hefei | Hefei | Anhui | China |
| The Second Hospital of Hefei | Hefei | Anhui | China |
| The Second People's Hospital of Anhui | Hefei | Anhui | China |
| the people's Hospital of Liuan | Liuan | Anhui | China |
| the people's Hospital of Tongling | Tongling | Anhui | China |
| The First Affiliated Hospital of Wannan Medical College | Wuhu | Anhui | China |
| The second People's Hospital of Wuhu | Wuhu | Anhui | China |
| ID | Term |
|---|---|
| D003693 | Delirium |
| 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 |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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