Status:
UNKNOWN
Cyclopofol Versus Propofol for Postoperative Delirium in Elderly Patients Having Orthopedic Surgery
Lead Sponsor:
RenJi Hospital
Collaborating Sponsors:
Haisco Pharmaceutical Group Co., Ltd.
Conditions:
Postoperative Delirium
Stroke
Eligibility:
All Genders
65-90 years
Phase:
PHASE4
Brief 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...
Detailed Description
Postoperative delirium (POD) is common in elderly patients after surgery and anesthesia which occurs within 24 to 72 hours after surgery. POD has adverse effects on early and long-term prognosis, incl...
Eligibility Criteria
Inclusion
- Age 65 to 90 years old (including the critical value), male or female;
- 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;
- ASA II-III;
- Preoperative mild cognitive function changes (MMSE score 21-26);
- 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;
- The expected hospital stay is at least 2 days;
- Agree to participate and give written informed consent.
Exclusion
- Patients with preoperative delirium (3D-CAM positive);
- Patients with severe cognitive impairment (MMSE score \<15);
- 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;
- 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);
- The surgical site interferes with the placement of BIS electrodes;
- Mental or language barriers impede data collection; Other reasons (such as hearing impairment or visual impairment) could not complete the MMSE, MoCA scales.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06046638
Start Date
October 1 2023
End Date
December 31 2024
Last Update
September 21 2023
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