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It has been proved that lithium carbonate can prolong slow wave sleep with few or no side-effects. The aim of the present study is to evaluate postoperative sleep quality of patients undergoing heart valve surgery with cardiopulmonary bypass taken 250mg lithium carbonate after surgery.
This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All patients undergoing heart valve surgery with cardiopulmonary bypass will be randomized 1:1 to the treatment intervention with lithium carbonate 250mg (Baoqing, Hunan, China) or calcium carbonate 500mg (Reneed, Beijing, China) after surgery. The objective of the trial is to evaluate the lithium carbonate 250mg on the postoperative night sleep quality. Duration of sleep was collected with polysomnography on second postoperative night. (from 20:00pm to 06:00. Mini-Mental State Examination (MMSE) score was performed on the seventh postoperative day
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lithium carbonate | Experimental | Patients undergoing heart valve surgery with cardiopulmonary bypass will take 250mg lithium carbonate . |
|
| calcium carbonate | Placebo Comparator | Patients undergoing heart valve surgery with cardiopulmonary bypass will take 500mg calcium carbonate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lithium Carbonate 250 MG Oral Tablet | Drug | Patients undergoing heart valve surgery withcardiopulmonary bypass will take 250mg lithium carbonate |
|
| Measure | Description | Time Frame |
|---|---|---|
| sleep quality | Duration of sleep was collected with polysomnography on second postoperative night. (from 20:00pm to 06:00am) | on the second postoperative night from 20:00 to 6:00 |
| Measure | Description | Time Frame |
|---|---|---|
| serum metabolites | This study will characterize the serum metabolites of patients before and after heart valve surgery | from baseline to postoperative 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function | Mini-Mental State Examination (MMSE) score was performed | on the seventh postoperative day |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenfei Tan | Contact | 024-83283100 | winfieldtan@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110001 | China |
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| Calcium Carbonate 500 MG Oral Tablet | Drug | Patients undergoing heart valve surgery withcardiopulmonary bypass will take 500mg calcium carbonate |
|
| ID | Term |
|---|---|
| D016651 | Lithium Carbonate |
| D013607 | Tablets |
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D002254 | Carbonates |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D018020 | Lithium Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D017610 | Calcium Compounds |
| D008903 | Minerals |
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