Postoperative Delirium and Postoperative Cognitive Dysfunction
Conditions
Interventions
experimental group:2mg/kg MB diluted with normal saline into total 50ml volume intravenous administration after induction of anesthesia for one hour
1mg/kg MB diluted with normal saline into total 50ml volume intravenous administration before the end of surgery within 30 minutes.
control group:normal saline in total 50ml volume intravenous administration after induction of anesthesia for one hour
normal saline in total 50ml volume intravenous administration before the end of surgery within 30 minutes.
Sponsors
Fundan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years; 2. Planning to undergo pancreatic tumor surgery; 3. MMSE >= 24; 4. Patients have the ability to act in full spirit, understand and sign the informed consent, and are willing to complete the whole research process.
Exclusion criteria
Exclusion criteria: 1.History of allergy to MB; 2.Patients with 6-phospho-glucose dehydrogenase deficiency (favism); 3.Recent drug administration that may lead to drug interactions, such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs); 4.Pregnant or lactating women; 5.Patients diagnosed with rheumatoid diseases such as systemic lupus erythematosus, rheumatoid arthritis and ankylosing spondylitis; 6.History of major head trauma; 7.Drug or alcohol abuse; 8.History of neurodegenerative diseases such as dementia or Parkinson's disease; 9.History of mental illness such as schizophrenia or depression; 10.Patients with delirium before surgery; 11.Illiterate patients 12.Serious medical diseases (ie. heart failure, pulmonary hypertension, acute stage of myocardial infarction or respiratory failure) 13.Severe language, visual or auditory deficiency 14. Participated in other clinical trials within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| postoperative delirium (POD); | — |
Secondary
| Measure | Time frame |
|---|---|
| postoperative cognitive dysfunction (POCD);adverse events;overall survival;disease-free survival;progression-free survival;Neurofilament Light;IL-1ß;IL-6;CRP;melatonin; | — |
Countries
China
Contacts
Public ContactJun Zhang
Fundan University Shanghai Cancer Center
Outcome results
None listed