The Effect of Desflurane on Postopertative Cognitive Dysfunction

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of desflurane on postoperative cognitive dysfunction

Detailed Description
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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.

Official Title
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A Study Evaluating the Effect of Desflurane in Preventing Postoperative Cognitive Dysfunction

Conditions
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Postoperative Cognitive Dysfunction, Postoperative Delirium

Intervention / Treatment
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* Drug: Desﬂurane
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desflurane<br>Patients allocated to this arm will receive desflurane during the maintenance of anesthesia. | Drug: Desﬂurane<br>* Investigators administrated desflurane with target of BIS 40-60 during the maintenance of anesthesia<br>|
| Placebo Comparator: Propofol<br>Patients allocated to this arm will receive propofol during the maintenance of anesthesia | Drug: Propofol<br>* Investigators administrated propofol with target of BIS 40-60 during the maintenance of anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative cognitive dysfunction | Screening of the patients regarding an postoperative cognitive dysfunction by TICS-M.TICS-M is assessed at 30 days after surgery | on the 30th day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative delirium | Screening of the patients regarding a postoperative delirium by The Confusion Assessment Method for The Intensive Care Unit (CAM-ICU) | 1-7days after surgery, on the 30th day after surgery | 
| Postoperative Pain | 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. | Within 3 days after surgery | 
| EEG frequency spectrum | 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: Five minutes before anesthesia introduction During the entire operation At discharge from post-anesthesia care unit (PACU) | 5 minutes before anesthesia introduction to 5 minutes before discharge from PACU | 
| Mortality |  | Within 30 days after surgery | 
| Length of Hospital stay |  | From the date of admission until discharged from hospital, within 30 days | 
| Hospital readmission | Hospital readmission during the follow up | Within 30 days after surgery | 
| Incidence of postoperative nausea and vomiting |  | Within 7 days after surgery | 
| Adverse events | Other adverse events within 3 days after surgery were noted | Within 30 days after surgery | 
| Neural and hemodynamic responses during desflurane general anesthesia | 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. | 5 minutes before anesthesia introduction to 5 minutes after emergence |