NCT06674226 Effects of Ciprofol on Postoperative Delirium and Outcomes in Elderly Patients Undergoing Major Thoracic Surgery
| NCT ID | NCT06674226 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Wang Tianlong |
| Condition | Postoperative Delirium (POD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 214 participants |
| Start Date | 2024-12-23 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 214 participants in total. It began in 2024-12-23 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Age ≥65 years old, gender unlimited; * Selective thoracoscopic lobectomy and segmental lung resection were performed, and the estimated time of anesthesia (from the beginning of anesthesia to the end of surgery) was ≥2 hours; * ASA score is Grade I \~III; (Annex 1) * A BMI of 18.5 to 29.9 kg/m2 \[BMI= weight (Kg)/height (m) 2\] (2013 U.S. Guidelines for the Management of Overweight and Obesity in Adults); * Postoperative hospital stay more than 72 hours; * Ethical, patients voluntarily take the test and sign the informed consent. Exclusion Criteria: * Emergency surgery; Hypovolemia, shock or coma; * In addition to general intravenous anesthesia, other anesthesia methods should be combined, such as inhalation anesthesia, epidural anesthesia, peripheral nerve block, etc., but it is not necessary to exclude patients with local infiltration of local anesthetic incision; * Serious cardiovascular disease, including a history of myocardial infarction within 6 months, bradycardia (resting heart rate \< 50 beats/min); Patients with hypertension whose blood pressure is not satisfactorily controlled (seated systolic blood pressure ≥160 mmHg during screening, and/or diastolic blood pressure ≥100 mmHg during screening); Sitting systolic blood pressure ≤90 mmHg during the screening period; A history of severe heart valve disease. * Abnormal liver function, AST and/or ALT≥2.5×ULN, TBIL≥1.5×ULN; * Abnormal renal function, urea or urea nitrogen ≥1.5×ULN, blood creatinine greater than the upper limit of normal; * Glycated hemoglobin (HbA1c) ≥ 8.5%, fasting blood glucose ≥180 mg/dl (10 mmol/L), blood glucose ≥270mg/dl (15mmol/L) 1 hour after meals, or blood glucose ≥216 mg/dl (12mmol/L) 2 hours after meals; * Patients with type I and type II expiratory failure * Preoperative anemia (Hb≤90 g/L), thrombocytopenia (PLT≤80×109/L), hypoproteinemia (Alb≤30 g/L); * A history of drug use and/or alcohol abuse within the 2 years prior to screening, with alcohol abuse being an average consumption of more than 2 units of alcohol per day (1 unit =360 mL beer or 150 mL of 45 mL liquor or wine with an alcohol concentration of 40%); * Patients with neurological diseases (stroke, Alzheimer's disease, Parkinson's disease, mental illness, myasthenia grave, etc., within 6 months), psychiatric diseases (schizophrenia, mania, bipolar disorder, insanity, etc.), long-term history of taking psychiatric drugs and cognitive impairment (using the simple mental State Assessment Form (MMSE scale (Annex 2)); * Patients who take sedative sleeping drugs and antiepileptic drugs for a long time; * Allergic to the investigational drug or contraindicated; * Participated in other drug clinical trials as a subject within the last 3 months; * Patients who refused or were unable to cooperate with the study; * Other conditions that the investigator considers inappropriate to participate in this study.
Contact & Investigator
Tianlong Wang, Doctor
PRINCIPAL INVESTIGATOR
Xuanwu Hospital, Beijing
Frequently Asked Questions
Who can join the NCT06674226 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Postoperative Delirium (POD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06674226 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06674226 currently recruiting?
Yes, NCT06674226 is actively recruiting participants. Contact the research team at w_tl5595@hotmail.com for enrollment information.
Where is the NCT06674226 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Guangzhou, China, Shijiazhuang, China and 5 additional locations.
Who is sponsoring the NCT06674226 clinical trial?
NCT06674226 is sponsored by Wang Tianlong. The principal investigator is Tianlong Wang, Doctor at Xuanwu Hospital, Beijing. The trial plans to enroll 214 participants.