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

Heart Valve Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05593627
• Other study ID #: 20220920-03
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2023
• Est. completion date: July 30, 2026

Study information

• Verified date: July 2023
• Source: China Medical University, China
• Contact: Wenfei Tan
• Phone: 024-83283100
• Email: winfieldtan[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: July 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Valve Surgery

Intervention

Drug:
• Lithium Carbonate 250 MG Oral Tablet
Patients undergoing heart valve surgery withcardiopulmonary bypass will take 250mg lithium carbonate
• Calcium Carbonate 500 MG Oral Tablet
Patients undergoing heart valve surgery withcardiopulmonary bypass will take 500mg calcium carbonate

Locations

Country	Name	City	State
China	the First Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognitive function	Mini-Mental State Examination (MMSE) score was performed	on the seventh postoperative day
Primary	sleep quality	Duration of sleep was collected with polysomnography on second postoperative night. (from 20:00pm to 06:00am)	on the second postoperative night from 20:00 to 6:00
Secondary	serum metabolites	This study will characterize the serum metabolites of patients before and after heart valve surgery	from baseline to postoperative 72 hours