Postoperative Delirium
Conditions
Interventions
intervention group:rScO2 and BIS-guided intraoperative anesthesia
control group:BIS-guided intraoperative anesthesia
Sponsors
Dept. of Anesthesiology, Changzheng Hospital Affiliated to the Second Military Medical Univiersity
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: Before recruitment, all potential candidates are subject to psychiatric review for cognition using the Mini Mental State Examination which is an 11-question tool consisting of five aspects related to cognitive function: orientation, registration, attention and calculation, recall, and language. As depression is also an independent risk of delirium, the 15-item Geriatric Depression Scale is used to screen the patients for depression. The eligible patients must meet all the following criteria: The eligible patients must meet all the following criteria: 1. Patients are aware of the study about the purpose, gains and possible harms and have signed the informed consent at his/her own will; 2. Patients are more than 70 years old, fluent in Chinese and have no serious hearing or vision impairments 3. Patients are diagnosed with esophageal cancer and scheduled for esophagectomy 4. A GDS score of less than 5 is needed. 5. Patients must have no history of neuropsychiatric disorders, alcoholism, substance abuse, or intake of psychotropic medications.
Exclusion criteria
Exclusion criteria: Patients are excluded if they meet one of the following criteria: 1. Patients show no will to participate in the study or refuse to sign the informed consent; 2. Patients are registered in other clinical trials; 3. Patients have a history of neurological and psychotic disorders (for example delirium, severe dementia (MMSE<10), Parkinsons disease, depression, seizure and schizophrenia); 4. Patients are taking cholinesterase inhibitors, haloperidol or other atypical antipsychotics; 5. Patients were diagnosed with stroke, myocardial ischemia or heart failure in recent 6 months; 6. Patients have a contraindication to haloperidol; 7. Patients have head skin injury, infections or ulcers which preclude the attachment of electrodes; 8. The EEG of patients shows prolonged corrected QT (QTc) interval of 460 ms or higher for men and 470 ms or higher for women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the incidence of postoperative delirium; | — |
Secondary
| Measure | Time frame |
|---|---|
| the time to the onset of postoperative delirium;the duration of postoperative delirium;the severity of postoperative delirium; | — |
Countries
China
Contacts
Public ContactShi Xueyin
Shanghai Changzheng Hospital
Outcome results
None listed