Impact of Lithium on Sleep and Cognitive Function After Heart Valve Surgery
Effect of Lithium Carbonate on Postoperative Sleep and Cognitive Function in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass
This study is testing if giving lithium after heart valve surgery can improve sleep quality and brain function for patients recovering from the procedure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | China Medical University, China Academic / other |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT05593627 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of lithium carbonate on postoperative sleep quality and cognitive function in patients undergoing heart valve surgery with cardiopulmonary bypass. It is a prospective, randomized, controlled trial where participants will receive either lithium carbonate or calcium carbonate after surgery. The primary outcome will be assessed through polysomnography to measure sleep duration on the second postoperative night, alongside cognitive assessment using the Mini-Mental State Examination on the seventh postoperative day.
Who should consider this trial
Good fit: Ideal candidates are ethnic Chinese adults aged 18 to 65 undergoing heart valve surgery with cardiopulmonary bypass.
Not a fit: Patients with preoperative sleep issues, cognitive difficulties, or certain medical histories may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve postoperative sleep quality and cognitive function in heart valve surgery patients.
How similar studies have performed: While lithium's effects on sleep have been noted, this specific application in postoperative heart valve surgery is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shenyang, Liaoning
- the First Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Study coordinator: Wenfei Tan
- Email: winfieldtan@hotmail.com
- Phone: 024-83283100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.