Perioperative Neurocognitive Disorders
Conditions
Interventions
Treatment Group:Continuous and slow intravenous infusion of Ganfu'neng 500 mg 1 hour before operation (0.9% normal saline 250 ml dilution, infusion rate: 250 ml / h)
Placebo Group:Continuous slow intravenous infusion of equal volume of water 1 hour before operation (0.9% saline 250 ml, infusion rate: 250ml / h)
Sponsors
Department of Anesthesiology and Perioperative medicine, Shanghai Fourth People’s Hospital, School of Medicine, Tongji University
Eligibility
Sex/Gender
All
Age
65 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1) Age over 65 years old; 2) Scheduled for Total Knee Replacement, Total Hip Replacement, or hip fracture under general anesthesia. Estimated anesthesia and surgery time over 1 hour; 3) Signed written informed consent obtained.
Exclusion criteria
Exclusion criteria: 1) Disease of the central nervous system, including all kinds of dementia, and depression; 2) MMSE score lower than 24; 3) Education time 177 umol/L); 10) Alcohol or drug addicted, had drank more than 5u of liqueur for the past 3 months. One unit equals 10ml or 8g pure alcohol; 11) Second surgery of the same elected patients, no matter the cause of surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of PND one day before discharge (or 7 days after operation); | — |
Secondary
| Measure | Time frame |
|---|---|
| Anxiety / depression state of patients 7 days after operation / before discharge;Activities of daily living of patients with telephone follow-up 3 months after operation;The levels of serum homocysteine (Hcy), ubiquitin carboxyl terminal hydrolase 25 (USP25) and free myeloid differentiation factor 2 (MD2) will be measured immediately before operation (before administration), immediately after operation and 24 hours after operation (morning blood on the first day after operation);Postoperative hospital stay;Incidence of postoperative complications; | — |
Countries
China
Contacts
Public ContactXiong Lize
Shanghai Fourth People’s Hospital, School of Medicine, Tongji University
Outcome results
None listed