Postoperative Cognitive Dysfunction, Postoperative Delirium
Conditions
Brief summary
The purpose of this study is to determine the effect of desflurane on postoperative cognitive dysfunction
Detailed description
Postoperative cognitive dysfunction is a common complication during postoperative period，especially in elderly patients. It is characterized by cognitive decline, inattention and abnormal mental status following surgery. The presence of postoperative cognitive dysfunction is independently associated with poor recovery, increased hospital length of stay and increased mortality. Desflurane is a widely used volatile anesthetic, associated with shorter emergence times than other volatile anesthetics. This study aims to access the effect of desflurane in preventing postoperative cognitive dysfunction.
Interventions
DRUGDesflurane
Investigators administrated desflurane with target of BIS 40-60 during the maintenance of anesthesia
DRUGPropofol
Investigators administrated propofol with target of BIS 40-60 during the maintenance of anesthesia
Sponsors
Beijing Chao Yang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Written consent given * 2\. Scheduled to undergo elective non-cardiac surgeries under general anesthesia * 3\. ASA Physical Score I-III
Exclusion criteria
* 1\. Patients with a history of neurological disease, such as Alzheimer disease. * 2\. Patients with a history of psychiatric disease * 3\. Patients with a medication history of antipsychotic drugs. * 4\. Unable to complete neuropsychological testing including patients with severe visual or hearing impairment. * 5\. Patients with preoperative delirium. * 6\. Patients who have severe adverse events, such as cardiac arrest. * 7\. Patients who preoperative MMSE score are below 20; * 8\. Patients who undergo second operation in a short period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative cognitive dysfunction | on the 30th day after surgery | Screening of the patients regarding an postoperative cognitive dysfunction by TICS-M.TICS-M is assessed at 30 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | Within 3 days after surgery | Visual Analogue Scale will be used to assess postoperative pain of patients. Numerical rating scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain. |
| EEG frequency spectrum | 5 minutes before anesthesia introduction to 5 minutes before discharge from PACU | Electroencephalography will be recorded at different points of time as follows and EEG characteristics including power in alpha, beta, theta, delta, gamma, spectrum will be extracted using MATLAB: 1. Five minutes before anesthesia introduction 2. During the entire operation 3. At discharge from post-anesthesia care unit (PACU) |
| Mortality | Within 30 days after surgery | — |
| Length of Hospital stay | From the date of admission until discharged from hospital, within 30 days | — |
| Incidence of postoperative delirium | 1-7days after surgery, on the 30th day after surgery | Screening of the patients regarding a postoperative delirium by The Confusion Assessment Method for The Intensive Care Unit (CAM-ICU) |
| Incidence of postoperative nausea and vomiting | Within 7 days after surgery | — |
| Adverse events | Within 30 days after surgery | Other adverse events within 3 days after surgery were noted |
| Neural and hemodynamic responses during desflurane general anesthesia | 5 minutes before anesthesia introduction to 5 minutes after emergence | Functional near-infrared spectroscopy (fNIRS) will be monitored from pre-anesthesia to the emergence. △\[HbO\] ，△\[Hb\] will be recorded. Besides, the coupling of fNIRS signals with neuronal signals (EEG) will be calculated. Furthermore, sample entrophy and the phase difference between △\[HbO\] and △\[Hb\] will be measured. |
| Hospital readmission | Within 30 days after surgery | Hospital readmission during the follow up |
Countries
China
Outcome results
None listed