Effects of Ciprofol on Postoperative Delirium and Outcomes in Elderly Patients Undergoing Major Thoracic Surgery

Launched by WANG TIANLONG · Nov 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Ciprofol on elderly patients who are undergoing major thoracic surgery. The focus is on understanding whether Ciprofol can help reduce the risk of postoperative delirium (POD), a condition where patients experience confusion and disorientation after surgery. Many older adults are at risk for POD, especially when they have surgery, and Ciprofol may offer a safer alternative to the commonly used anesthetic propofol, as it has shown to have fewer side effects and more stable effects on blood pressure.

To be eligible for this trial, participants must be at least 65 years old and scheduled for a specific type of lung surgery that requires general anesthesia for at least two hours. They should also have a body weight within a healthy range and be able to provide informed consent. During the study, participants will receive either Ciprofol or propofol during their surgery, and the researchers will monitor their recovery to see how each medication affects the likelihood of developing POD. It's important to note that individuals with certain health conditions, such as severe heart or liver issues, or those taking specific medications, may not qualify for the trial. This study aims to provide valuable information that could help improve care for older patients undergoing surgeries in the future.

Gender

ALL

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.