Effect of Lithium Carbonate on Postoperative Sleep and Cognitive Function in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- sleep quality
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ethnic Chinese;
- •Age, 18 to 65 years old;
- •Patients undergoing heart valve surgery with cardiopulmonary bypass
排除标准
- •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
研究组 & 干预措施
lithium carbonate
Patients undergoing heart valve surgery with cardiopulmonary bypass will take 250mg lithium carbonate .
干预措施: Lithium Carbonate 250 MG Oral Tablet (Drug)
calcium carbonate
Patients undergoing heart valve surgery with cardiopulmonary bypass will take 500mg calcium carbonate.
干预措施: Calcium Carbonate 500 MG Oral Tablet (Drug)
结局指标
主要结局
sleep quality
时间窗: 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)
次要结局
- serum metabolites(from baseline to postoperative 72 hours)
研究者
Wenfei Tan
Professor
China Medical University, China