Ciprofol's effects on delirium in elderly patients after thoracic surgery

Effects of Ciprofol on Postoperative Delirium and Outcomes in Elderly Patients Undergoing Major Thoracic Surgery: a Multicentre, Prospective, Single-blind, Randomized Controlled Study

This study is testing whether ciprofol can help reduce the chances of delirium in older patients after they have major chest surgery, compared to the usual medication propofol.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 214 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 9 sites (Beijing, Beijing Municipality and 8 other locations)
• Trial ID: NCT06674226 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of ciprofol compared to propofol on the incidence of postoperative delirium (POD) in elderly patients undergoing major thoracic surgery. It is a prospective, single-blinded, randomized controlled trial involving patients aged 65 and older who are scheduled for elective thoracoscopic lobectomy or pulmonary segmentation. Participants will be randomly assigned to receive either ciprofol or propofol during anesthesia, and their outcomes will be monitored for POD incidence from the first to the seventh day post-surgery or until discharge. The primary endpoint is the rate of delirium occurrence in these patients.

Who should consider this trial

Good fit: Ideal candidates are elderly patients aged 65 and older undergoing elective thoracoscopic lobectomy or pulmonary segmentation with an estimated anesthesia time of at least 2 hours.

Not a fit: Patients undergoing emergency surgery or those with serious cardiovascular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for preventing postoperative delirium in elderly patients, enhancing their recovery and overall outcomes.

How similar studies have performed: While there is limited evidence regarding specific anesthetic agents for preventing POD, this study's approach is novel and aims to fill a significant gap in current knowledge.

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.

Where this trial is running

Beijing, Beijing Municipality and 8 other locations

• Xuanwu Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Xuanwu Hospital — Beijing, Beijing Municipality, China (Recruiting)
• The First Affiliated Hospital, Jinan University — Guangzhou, Guangdong, China (Recruiting)
• The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)
• Tongji Hospital — Wuhan, Hubei, China (Recruiting)
• The third Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
• Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
• Drum Tower Hospital — Nanjing, Jiangsu, China (Recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)

Study contacts

• Principal investigator: Tianlong Wang, Doctor — Xuanwu Hospital, Beijing
• Study coordinator: Tianlong Wang

Conditions Postoperative Delirium