Effect of Ciprofol Injection on Postoperative Cognitive Function
2026年6月25日 更新者：Guangyou Duan、The Second Affiliated Hospital of Chongqing Medical University
A Controlled Study on the Impact of Ciprofol Injection on Postoperative Cognitive Function and Its Mechanism
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.
研究概览
研究类型
介入性
注册 (估计的)
298
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Chongqing Municipality
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Chongqing、Chongqing Municipality、中国、400010
- The Second Affiliated Hospital of Chongqing Medical University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Experimental group (ciprofol)
patients in the Ciprofol group will use ciprofol to complete the painless gastroscopy and colonoscopy treatment.
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patients in the Ciprofol group will use ciprofol to complete the painless gastroscopy and colonoscopy treatment.
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有源比较器：Control group (propofol)
patients in the propofol group will use propofol to complete the painless gastroscopy and colonoscopy treatment.
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patients in the propofol group will use propofol to complete the painless gastroscopy and colonoscopy treatment.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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The difference in the incidence of cognitive function decline between ciprofol and propofol in patients undergoing painless gastroscopy and colonoscopy treatment
大体时间：From the time the patient was enrolled in the study to 24 hours after the treatment
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From the time the patient was enrolled in the study to 24 hours after the treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Intraoperative and postoperative adverse events
大体时间：From the time the patient enters the operating room to 24 hours after the treatment
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From the time the patient enters the operating room to 24 hours after the treatment
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Blood Pressure (mmHg)
大体时间：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)
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Non-invasive BP measured by cuff after entry and intermittently during surgery.
Hypotension: SBP decrease >30% from baseline; Hypertension: SBP increase >30% from baseline.
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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)
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Heart Rate (beats/min)
大体时间：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)
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Read from monitor.
Bradycardia: <50 bpm or decrease ≥25% from baseline; Tachycardia: >100 bpm or increase ≥25% from baseline.
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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)
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Respiratory Rate (breaths/min)
大体时间：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)
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Read from monitor or counted over 1 min.
Respiratory depression: <8 breaths/min lasting >30 sec.
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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)
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Oxygen Saturation (Pulse Oximetry)
大体时间：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)
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Read from monitor.
Hypoxemia: SpO2 <90% lasting >15 sec.
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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)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The dosage of propofol/ciprofol used
大体时间：The dosage of drugs used during this period from anesthesia induction to the end of anesthesia (perioperative period) (approximately 25 - 60 minutes)
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The dosage of drugs used during this period from anesthesia induction to the end of anesthesia (perioperative period) (approximately 25 - 60 minutes)
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The patient's stay time in the PACU（Post-Anesthesia Care Unit）
大体时间：up to 24 hours
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The period from when the patients enter the PACU until they leave the PACU
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up to 24 hours
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Guangyou Duan、The Second Affiliated Hospital of Chongqing Medical University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月1日
初级完成 (估计的)
2026年12月30日
研究完成 (估计的)
2026年12月30日
研究注册日期
首次提交
2026年6月9日
首先提交符合 QC 标准的
2026年6月25日
首次发布 (实际的)
2026年6月29日
研究记录更新
最后更新发布 (实际的)
2026年6月29日
上次提交的符合 QC 标准的更新
2026年6月25日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.