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

Phase 4

Recruiting

• Conditions: Heart Valve Surgery
• Interventions: Drug: Lithium Carbonate 250 MG Oral Tablet; Drug: Calcium Carbonate 500 MG Oral Tablet

• Registration Number: NCT05593627
• Lead Sponsor: China Medical University, China

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

Study Timeline

• Study First Submitted: 2022-10-21
• Study First Submitted QC: 2022-10-21
• Study First Posted: 2022-10-25
• Status Verified: 2023-07
• Study Start: 2023-07-01
• Last Update Submitted: 2023-07-14
• Last Update Posted: 2023-07-18
• Primary Completion: 2025-12-31
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lithium carbonate	Lithium Carbonate 250 MG Oral Tablet	Patients undergoing heart valve surgery with cardiopulmonary bypass will take 250mg lithium carbonate .
calcium carbonate	Calcium Carbonate 500 MG Oral Tablet	Patients undergoing heart valve surgery with cardiopulmonary bypass will take 500mg calcium carbonate.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
serum metabolites	from baseline to postoperative 72 hours	This study will characterize the serum metabolites of patients before and after heart valve surgery

Trial Locations

Locations (1)

the First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China