Tubeless Anesthesia With Preserved Spontaneous Breathing and the Construction of a Perioperative Brain Health Safety System for Thoracic Surgery Patients Study 2: A Prospective Clinical Study Observing the Impact of Two Anesthesia Techniques-Tubeless With Preserved Spontaneous Breathing Versus Double-Lumen Endotracheal Intubation-on Perioperative Brain Health
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Concentration of cognitive function biomarkers in the serum samples of 400 patients
研究概览
简要总结
This project conducts a prospective cohort study. By using multiple questionnaire survey methods such as the Pittsburgh Sleep Quality Index (PSQI) electronic wristband, QOR15, Pain Catastrophizing Scale (PCS), European Five-Dimensional Health Scale (EQ-5D), Revised American Pain Society Patient Follow-up Questionnaire (APS-POQ-R), Mini-Mental State Examination (MMSE), as well as perioperative stress and related indicators, hypothalamic-pituitary-adrenal axis (HPA) endocrine indicators, sublingual microcirculation, electroencephalogram, etc., comprehensive assessment is made of the correlations between the two different anesthesia methods of Tubeless retention of spontaneous breathing and double-lumen bronchial intubation and postoperative sleep, chronic pain and cognitive function, to construct a perioperative brain health safety system to improve prognosis; at the same time, optimize the perioperative sedation and analgesia plan and promote the postoperative brain health recovery of patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age: 18 - 75 years old
- •Patients meeting the standards of the American Society of Anesthesiologists (ASA) I-III grade and the New York Heart Association (NYHA) I-II class
- •Body Mass Index (BMI) < 30 kg/m2
- •Intraoperative blood loss less than 300 ml
- •No severe cardiac or pulmonary dysfunction [first-second forced vital capacity (FEV1%) predicted value] > 50%, ejection fraction (EF) > 50%
- •No contraindications related to paravertebral nerve block and intercostal nerve block
- •Able to sign the informed consent form and possess communication, reading and writing abilities
- •Postoperative hospital stay of at least one day
- •No preoperative sleep disorders, no cognitive dysfunction (PSQI ≤ 10 points, PCS ≤ 38 points, MMSE > 27 points)
排除标准
- •Already diagnosed with a mental disorder or had a preoperative Mini-Mental State Examination (MMSE) score of less than 27
- •History of opioid abuse
- •Patients who were admitted to the ICU after surgery
- •Have severe cardiovascular, respiratory diseases
- •Experienced critical rescue during or after the surgery
- •Complicated with coagulation dysfunction, severe hypoxia or hypercapnia, or liver and kidney dysfunction
- •Difficult airway management
- •Changed anesthetic agent or surgical plan
- •Severe lacunar cerebral infarction, ischemic stroke or other neurological diseases
- •Changed anesthetic agent or surgical plan during the surgery;
结局指标
主要结局
Concentration of cognitive function biomarkers in the serum samples of 400 patients
时间窗: Before the start of the surgery (T1), at the end of the surgery (T2), and on the first day after the surgery (T3)
At time points T1, T2, and T3, 5 ml of peripheral venous blood was collected to test the biological indicators of postoperative cognitive function.
Concentrations of HPA axis-related indicators in the serum samples of 400 patients
时间窗: Before the start of the surgery (T1), at the end of the surgery (T2)
At the TI-T2 time point, 5 ml of peripheral venous blood was collected for the detection of HPA axis-related indicators.
The concentrations of laboratory test indicators in the serum samples of 400 patients
时间窗: Before the start of the surgery (T1), and on the first day after the surgery (T3)
Record the laboratory test indicators at time points T1 and T3
次要结局
- Anesthesia Record Form(at the end of the surgery (T2))
- Case information system collection(Before the start of the surgery (T1), and on the first day after the surgery (T3))
- Anesthesia Record Form(During the operation)
- Postoperative follow-up records(through study completion, an average of 1 year)
研究者
Fengfa Yang
Principal Investigator
Guangzhou Medical University