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

ConditionHeart Valve Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChina Medical University, China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ethnic Chinese;

Age, 18 to 65 years old;

Patients undergoing heart valve surgery with cardiopulmonary bypass

Disqualifiers

Preoperative Pittsburgh Sleep Quality Index global scores higher than 6

Cognitive difficulties

Partial or complete gastrectomy

Previous esophageal surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lithium Carbonate 250 MG Oral Tablet

    Drug

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

  • Calcium Carbonate 500 MG Oral Tablet

    Drug

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

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: lithium carbonateExperimental treatment 1 intervention
Group B: calcium carbonatePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

sleep quality

Duration of sleep was collected with polysomnography on second postoperative night. (from 20:00pm to 06:00am)

Time frame
on the second postoperative night from 20:00 to 6:00

Secondary outcomes

1

serum metabolites

This study will characterize the serum metabolites of patients before and after heart valve surgery

Time frame
from baseline to postoperative 72 hours

Other outcomes

1

Cognitive function

Mini-Mental State Examination (MMSE) score was performed

Time frame
on the seventh postoperative day

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China Medical University, China

Lead sponsor

Source ClinicalTrials.gov
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