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NCT Number: NCT05593627

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

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.

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Key information

Conditions

Heart Valve Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location status: Recruiting

Location contact

Wenfei Tan, M.D.,Ph.D

CONTACT

[email protected]

024-83283100

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. sleep quality

    Time frame: 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 outcomes

  1. serum metabolites

    Time frame: from baseline to postoperative 72 hours

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

Other outcomes

  1. Cognitive function

    Time frame: on the seventh postoperative day

    Mini-Mental State Examination (MMSE) score was performed

Study contacts

Contact information is provided by the study sponsor or research team.

Wenfei Tan

CONTACT

[email protected]

024-83283100

Sponsors and collaborators

Lead sponsor

China Medical University, China

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 25, 2022
Registry last updated
Jul 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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