Effect of Lithium Carbonate on Postoperative Sleep and Cognitive Function in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Effect of Lithium Carbonate on Postoperative Sleep and Cognitive Function in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass

Conditions
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Heart Valve Surgery

Intervention / Treatment
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* Drug: Lithium Carbonate 250 MG Oral Tablet
* Drug: Calcium Carbonate 500 MG Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ethnic Chinese; Age, 18 to 65 years old; Patients undergoing heart valve surgery with cardiopulmonary bypass Exclusion Criteria: Preoperative Pittsburgh Sleep Quality Index global scores higher than 6 Cognitive difficulties Partial or complete gastrectomy Previous esophageal surgery Previous treated by radiotherapy or surgery Inability to conform to the study's requirements Body mass index exceeding 30 kg/m2 Deprivation of a right to decide by an administrative or juridical entity Ongoing participation or participation in another study <1 month ago Recent (< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or traditional Chinese medicine

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lithium carbonate<br>Patients undergoing heart valve surgery with cardiopulmonary bypass will take 250mg lithium carbonate . | Drug: Lithium Carbonate 250 MG Oral Tablet<br>* Patients undergoing heart valve surgery withcardiopulmonary bypass will take 250mg lithium carbonate<br>|
| Placebo Comparator: calcium carbonate<br>Patients undergoing heart valve surgery with cardiopulmonary bypass will take 500mg calcium carbonate. | Drug: Calcium Carbonate 500 MG Oral Tablet<br>* Patients undergoing heart valve surgery withcardiopulmonary bypass will take 500mg calcium carbonate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lithium carbonate, polysomnography