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

NCT ID: NCT05593627

Last Updated: 2023-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2026-07-30

Brief Summary

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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

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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

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Heart Valve Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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lithium carbonate

Patients undergoing heart valve surgery with cardiopulmonary bypass will take 250mg lithium carbonate .

Group Type EXPERIMENTAL

Lithium Carbonate 250 MG Oral Tablet

Intervention Type DRUG

Patients undergoing heart valve surgery withcardiopulmonary bypass will take 250mg lithium carbonate

calcium carbonate

Patients undergoing heart valve surgery with cardiopulmonary bypass will take 500mg calcium carbonate.

Group Type PLACEBO_COMPARATOR

Calcium Carbonate 500 MG Oral Tablet

Intervention Type DRUG

Patients undergoing heart valve surgery withcardiopulmonary bypass will take 500mg calcium carbonate

Interventions

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Lithium Carbonate 250 MG Oral Tablet

Patients undergoing heart valve surgery withcardiopulmonary bypass will take 250mg lithium carbonate

Intervention Type DRUG

Calcium Carbonate 500 MG Oral Tablet

Patients undergoing heart valve surgery withcardiopulmonary bypass will take 500mg calcium carbonate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Wenfei Tan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenfei Tan

Role: CONTACT

024-83283100

Facility Contacts

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Wenfei Tan, M.D.,Ph.D

Role: primary

024-83283100

Other Identifiers

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20220920-03

Identifier Type: -

Identifier Source: org_study_id

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