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Effects of Ciprofol on Postoperative Delirium and Outcomes in Elderly Patients Undergoing Major Thoracic Surgery
Led by Wang Tianlong · Updated on 2026-04-28
214
Participants Needed
9
Research Sites
79 weeks
Total Duration
On this page
Sponsors
W
Wang Tianlong
Lead Sponsor
X
Xiangya Hospital of Central South University
Collaborating Sponsor
AI-Summary
What this Trial Is About
There are many factors that make elderly patients prone to POD. On the basis of these factors, surgery and anesthesia can increase the incidence of POD in elderly patients. Deep depth of intraoperative anesthesia and persistent hypotension may increase the risk of POD occurrence in elderly patients. So far, no specific POD prevention method has been found. In recent years, a large number of studies on POD have brought forward more new views on its pathogenesis, prevention and treatment. There is insufficient evidence to recommend specific anesthetic agents and dosages to reduce the risk of POD in elderly patients, and only low-quality evidence to recommend propofol. At present, it is considered that the best way to reduce postoperative delirium is perioperative risk management, to evaluate high-risk patients or patients undergoing high-risk surgery as extensive as possible, and to quantify their risk of postoperative delirium. Effective measures include depth management of anesthesia, multi-modal analgesia management, and optimization of drug intervention. Ciprofol is a class 1 innovative drug independently developed by China and with global independent intellectual property rights. Ciprofol has been widely used in anesthesiology and critical care medicine. The pre-market phase I-III and post-market data showed that during the induction and maintenance of general anesthesia, Ciprofol had less impact on hemodynamics and more stable anesthesia depth than propofol. Relevant studies have shown that Ciprofol can reduce the risk of hypotension, and can provide better brain oxygenation and more stable intraoperative hemodynamics than propofol. At present, the influence of different sedative drugs on POD incidence in elderly patients remains to be studied. Therefore, we will apply Ciprofol or propofol in elderly patients undergoing thoracic surgery to observe their influence on POD incidence and provide reference for clinical use.
CONDITIONS
Official Title
Effects of Ciprofol on Postoperative Delirium and Outcomes in Elderly Patients Undergoing Major Thoracic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older, any gender
- Scheduled for elective thoracoscopic lobectomy or segmental lung resection with anesthesia time of at least 2 hours
- ASA physical status classification of Grade I to III
- Body mass index (BMI) between 18.5 and 29.9 kg/m2
- Expected postoperative hospital stay longer than 72 hours
- Voluntary participation with signed informed consent
You will not qualify if you...
- Emergency surgery or presence of hypovolemia, shock, or coma
- Use of anesthesia methods other than intravenous general anesthesia, except local anesthetic infiltration
- Serious cardiovascular conditions including myocardial infarction within 6 months, resting heart rate below 50 beats/min, uncontrolled hypertension, low blood pressure during screening, or severe heart valve disease
- Abnormal liver function with elevated AST/ALT or bilirubin levels
- Abnormal kidney function with elevated urea or creatinine levels
- Poorly controlled diabetes or high blood glucose levels
- Type I or II respiratory failure
- Preoperative anemia, low platelet count, or low blood protein levels
- History of drug or alcohol abuse within 2 years prior to screening
- Neurological diseases, psychiatric disorders, long-term use of psychiatric medications, or cognitive impairment
- Long-term use of sedative or antiepileptic drugs
- Allergy or contraindication to study drugs
- Participation in other drug trials within the last 3 months
- Refusal or inability to cooperate with the study
- Other conditions deemed unsuitable by the investigator
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Trial Site Locations
Total: 9 locations
1
Xuanwu Hospital
Beijing, Beijing Municipality, China, 100053
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2
Xuanwu Hospital
Beijing, Beijing Municipality, China, 100053
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3
The First Affiliated Hospital, Jinan University
Guangzhou, Guangdong, China
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4
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050030
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5
Tongji Hospital
Wuhan, Hubei, China, 430030
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6
The third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000
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7
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410008
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8
Drum Tower Hospital
Nanjing, Jiangsu, China, 210000
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9
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330038
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Research Team
T
Tianlong Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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