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

Launched by RENJI HOSPITAL · Sep 13, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether a new anesthetic called cyclopofol can help reduce the risk of postoperative delirium (POD) in elderly patients undergoing orthopedic surgery. POD is a common condition that can cause confusion and other problems after surgery, especially in older adults. The study aims to determine if cyclopofol, which has been shown to provide a more stable depth of anesthesia, can improve recovery and brain health in patients aged 65 to 90 who have mild cognitive changes and other health issues, like a history of stroke or diabetes.

To be eligible for this trial, participants should be scheduled for orthopedic surgery and expected to stay in the hospital for at least two days. They should also have mild cognitive changes and one or more existing health conditions. However, those with severe cognitive issues or specific psychological and heart conditions will not be able to participate. If you or a loved one qualifies, you will have the opportunity to contribute to important research that could improve care for older patients undergoing surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 65 to 90 years old (including the critical value), male or female;
• • 2. Scheduled to undergo orthopaedic surgery under general anesthesia, including femoral surgery, hip surgery, lumbar spine surgery, and do not plan to enter the ICU after surgery;
• • 3. ASA II-III;
• • 4. Preoperative mild cognitive function changes (MMSE score 21-26);
• • 5. Multiple coexisting diseases (at least one or more), including history of stroke (at least 6 months before elective surgery), hypertension, diabetes, ischemic heart disease, chronic obstructive pulmonary disease, obstructive sleep apnea, chronic kidney disease, hypoalbuminemia, anemia, water electricity and acid-base disorders;
• • 6. The expected hospital stay is at least 2 days;
• • 7. Agree to participate and give written informed consent.
• Exclusion Criteria:
• • 1. Patients with preoperative delirium (3D-CAM positive);
• • 2. Patients with severe cognitive impairment (MMSE score \<15);
• • 3. Patients with history of psychological and nervous system diseases (such as depression, schizophrenia, epilepsy, severe central nervous system depression, Parkinson's disease, Alzheimer's disease, myasthenia gravis, basal ganglia disease, etc.) that interfere with the judgment of curative effect indicators disease factors;
• • 4. Patients with severe congestive heart failure (New York Heart Association, class IV) or severe chronic obstructive pulmonary disease (Global Initiative for Chronic Obstructive Lung Disease guidelines, stage III-IV);
• • 5. The surgical site interferes with the placement of BIS electrodes;
• • 6. Mental or language barriers impede data collection; Other reasons (such as hearing impairment or visual impairment) could not complete the MMSE, MoCA scales.