Dynamic Effects of Different Anesthetic Agents on the Immune Function of Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Single-cell multi-omics data obtained from peripheral blood mononuclear cells; metabolome, lipidome, and proteome data obtained from plasma through detection; whole genome sequencing data.
研究概览
简要总结
This study recruits healthy volunteers and randomly assigns them in a 1:1:1:1 ratio to the following groups: Propofol group, Sevoflurane group, Ciprofol group, and Control group. Subjects in the different groups will undergo anesthesia with the corresponding general anesthetic drug, while subjects in the Control group will receive no anesthesia. Peripheral blood samples will be collected at specified time points: before anesthesia induction, upon emergence from anesthesia, 24 hours after anesthesia, and 48 hours after anesthesia. Single-cell multi-omics analysis will be performed on these samples using single-cell sequencing technology. The aim is to investigate the independent effects of different general anesthetic drugs on human immune function in the absence of surgical trauma, and to further explore the potential immunomodulatory effects of commonly used clinical anesthetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers undergo routine blood tests, liver function, kidney function, coagulation function, and routine 12-lead electrocardiogram examination before the trial. Any item showing no significant abnormalities; Age 20-30 years; ASA physical status I; BMI (Body Mass Index) 18-28 kg/m².
排除标准
- •History of neurological/psychiatric diseases, immune system diseases, or any type of chronic disease; History of surgical anesthesia; History of bad habits such as drug abuse, smoking or excessive drinking; Women during menstruation, pregnancy, or lactation; Recent use of immunosuppressants, hormones, non-steroidal anti-inflammatory drugs; Intake of antibiotics, probiotics, prebiotics, or other supplements within three months prior to stool sample collection; Recent history of diarrhea, inflammatory bowel disease, or other diseases severely affecting gut microbiota structure.
研究组 & 干预措施
Propofol group
Anesthesia induction: 1.5-2.5 mg/kg IV bolus; Anesthesia maintenance: 4-12 mg/kg/h infusion
干预措施: Propofol group (Drug)
Sevoflurane group
Anesthesia induction: 6% concentration inhaled for 2 minutes; Anesthesia maintenance: 0.5-3% concentration
干预措施: Sevoflurane group (Drug)
Ciprofol group
Anesthesia induction: 0.4 mg/kg IV injection over 10-30s; if anesthesia depth is insufficient, additional doses not exceeding 0.2 mg/kg may be given; Anesthesia maintenance: 0.4-2.4 mg/kg/h infusion
干预措施: Ciprofol group (Drug)
Control group
subjects will not undergo anesthesia but will remain in a supine position on a hospital trolley for 3 hours.
干预措施: Control group (Other)
结局指标
主要结局
Single-cell multi-omics data obtained from peripheral blood mononuclear cells; metabolome, lipidome, and proteome data obtained from plasma through detection; whole genome sequencing data.
时间窗: Peripheral blood samples will be collected at specified time points: before anesthesia induction, upon emergence from anesthesia, 24 hours after anesthesia, and 48 hours after anesthesia. Single-cell multi-omics analysis will be performed on these sample
次要结局
未报告次要终点