A Controlled Study on the Impact of Ciprofol Injection on Postoperative Cognitive Function and Its Mechanism
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 298
- 试验地点
- 1
- 主要终点
- The difference in the incidence of cognitive function decline between ciprofol and propofol in patients undergoing painless gastroscopy and colonoscopy treatment
研究概览
简要总结
This study aims to explore the effect of ciprofol on the postoperative cognitive function of inpatients undergoing gastrointestinal endoscopy examination, to compare the anesthetic effects and differences in adverse reactions of propofol and ciprofol in gastrointestinal endoscopy , to compare the incidence of postoperative cognitive decline in patients undergoing gastrointestinal endoscopy examination between propofol and coprofol, and to optimize the anesthesia medication regimen for patients undergoing gastrointestinal endoscopy examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
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
- 是
入选标准
- •Age: 18-65 years old, ASA grade I-Ⅲ, BMI index: 18.5-30 kg/m ²
- •Patients who plan to undergo gastroscopy or colonoscopy in our hospital
- •The preoperative assessment of the MOCA scale in patients scheduled for elective surgery indicated normal cognitive function
- •dextromanuality
- •Voluntarily participate in this study and sign the informed consent form
排除标准
- •Pregnant or lactating women
- •Patients who have had cardiovascular and cerebrovascular accidents in the past
- •Patients with severe diseases of the cardiovascular system, respiratory system and liver and kidney system
- •Patients with obstructive sleep apnea syndrome
- •Patients with concurrent neurological or mental system diseases, or those with incomplete intellectual development
- •Patients allergic to ciprofol or propofol drugs
- •Patients with braking, visual/auditory impairments
- •Patients with psychotropic drug addiction or alcohol dependence
- •Patients who themselves or their attending physicians refused to participate in the study
研究组 & 干预措施
Experimental group (ciprofol)
patients in the Ciprofol group will use ciprofol to complete the painless gastroscopy and colonoscopy treatment.
干预措施: Ciprofol group (Drug)
Control group (propofol)
patients in the propofol group will use propofol to complete the painless gastroscopy and colonoscopy treatment.
干预措施: Propofol group (Drug)
结局指标
主要结局
The difference in the incidence of cognitive function decline between ciprofol and propofol in patients undergoing painless gastroscopy and colonoscopy treatment
时间窗: From the time the patient was enrolled in the study to 24 hours after the treatment
次要结局
- Intraoperative and postoperative adverse events(From the time the patient enters the operating room to 24 hours after the treatment)
- Blood Pressure (mmHg)(From entering the operating room to leaving it (before anesthesia, after induction, and 5 minutes、10 minutes 、20 minutes 、30 minutes 、40 minutes、50 minutes、60 minutes after the operation began))
- Heart Rate (beats/min)(From entering the operating room to leaving it (before anesthesia, after induction, and 5 minutes、10 minutes 、20 minutes 、30 minutes 、40 minutes、50 minutes、60 minutes after the operation began))
- Respiratory Rate (breaths/min)(From entering the operating room to leaving it (before anesthesia, after induction, and 5 minutes、10 minutes 、20 minutes 、30 minutes 、40 minutes、50 minutes、60 minutes after the operation began))
- Oxygen Saturation (Pulse Oximetry)(From entering the operating room to leaving it (before anesthesia, after induction, and 5 minutes、10 minutes 、20 minutes 、30 minutes 、40 minutes、50 minutes、60 minutes after the operation began))
研究者
Guangyou Duan
professor
The Second Affiliated Hospital of Chongqing Medical University