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

China Medical University, China

Status and phase: Enrolling; Phase 4

Conditions: Heart Valve Surgery

Treatments: Drug: Lithium Carbonate 250 MG Oral Tablet; Drug: Calcium Carbonate 500 MG Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05593627

20220920-03

Details and patient eligibility

About

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.

Full 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

Enrollment: 62 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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62 participants in 2 patient groups, including a placebo group

lithium carbonate

Experimental group

Description:

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

Treatment:

Drug: Lithium Carbonate 250 MG Oral Tablet

calcium carbonate

Placebo Comparator group

Description:

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

Treatment:

Drug: Calcium Carbonate 500 MG Oral Tablet