drugset / Trial / NCT06046638

Cyclopofol Versus Propofol for Postoperative Delirium in Elderly Patients Having Orthopedic Surgery

NCT06046638 ↗

RandomizedParallel-groupDouble-blindDiagnostic

Summary

Postoperative delirium (POD) is common in elderly patients recovering from surgery and anesthesia. POD has adverse effects on early and long-term prognosis. The incidence of POD increases with age and patients with preoperative cognitive changes or coexisting diseases. The bispectral index (BIS) is an electroencephalographic measurement commonly used to monitor the depth of anesthesia. Low intraoperative BIS value (BIS\<40) and prolonged duration of low BIS value maybe risk factors of POD. A small sub-study of BALANCED Anaesthesia Study demonstrated a protective effect of targeting a BIS of 50 to reduce POD compared with a BIS of 35. The stability of BIS during general anesthesia may affect the risk of POD in elderly patients. Therefore, it is very important to maintain a stable BIS value as much as possible during general anesthesia surgery, and a general anesthetic with good BIS stability is even more needed in clinical practice. Cyclopofol is a new type of anesthetic/sedative that reportedly provides good efficacy and safety. Cyclopofol has a more stable effect on BIS, so whether the use of cyclopofol in elderly patients undergoing orthopedic surgery can reduce the occurrence of POD, improve prognosis, and exert a brain protective effect will be of great importance and clinical research value.

Timeline

Start
2023-10-01
Primary completion
2024-12-31
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclopofol Unknown 0.8 mg/kg —
Comparator Propofol Small molecule 5 mg/kg —