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Recruiting Phase 4 NCT05593627

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

Trial Parameters

Condition Heart Valve Surgery
Sponsor China Medical University, China
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 62
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2023-07-01
Completion 2025-12-31
Interventions
Lithium Carbonate 250 MG Oral TabletCalcium Carbonate 500 MG Oral Tablet

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.

Eligibility 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

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