Heart Valve Surgery
Conditions
Keywords
lithium carbonate, polysomnography
Brief summary
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
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
Interventions
DRUGLithium Carbonate 250 MG Oral Tablet
Patients undergoing heart valve surgery withcardiopulmonary bypass will take 250mg lithium carbonate
Patients undergoing heart valve surgery withcardiopulmonary bypass will take 500mg calcium carbonate
Sponsors
China Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sleep quality | on the second postoperative night from 20:00 to 6:00 | Duration of sleep was collected with polysomnography on second postoperative night. (from 20:00pm to 06:00am) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| serum metabolites | from baseline to postoperative 72 hours | This study will characterize the serum metabolites of patients before and after heart valve surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cognitive function | on the seventh postoperative day | Mini-Mental State Examination (MMSE) score was performed |
Countries
China
Contacts
Primary ContactWenfei Tan
Outcome results
None listed