NCT05593627

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: China Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Heart Valve Surgery

Interventions

Type	Name	Description
DRUG	Lithium Carbonate 250 MG Oral Tablet	Patients undergoing heart valve surgery withcardiopulmonary bypass will take 250mg lithium carbonate
DRUG	Calcium Carbonate 500 MG Oral Tablet	Patients undergoing heart valve surgery withcardiopulmonary bypass will take 500mg calcium carbonate

Timeline

• Start date: 2023-07-01
• Primary completion: 2025-12-31
• Completion: 2026-07-30
• First posted: 2022-10-25
• Last updated: 2023-07-18

Locations

1 site across 1 country: China