Postoperative Delirium Clinical Trial
Official title:
A Study Evaluating the Effect of Desflurane in Preventing Postoperative Cognitive Dysfunction
NCT number | NCT04541823 |
Other study ID # | 00375928 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 1, 2021 |
Est. completion date | March 2023 |
Verified date | August 2021 |
Source | Beijing Chao Yang Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the effect of desflurane on postoperative cognitive dysfunction
Status | Recruiting |
Enrollment | 100 |
Est. completion date | March 2023 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Chaoyang Hospital, Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Chao Yang Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Mortality | Within 30 days after surgery | ||
Secondary | Length of Hospital stay | From the date of admission until discharged from hospital, within 30 days | ||
Secondary | Hospital readmission | Hospital readmission during the follow up | Within 30 days after surgery | |
Secondary | Incidence of postoperative nausea and vomiting | Within 7 days after surgery | ||
Secondary | Adverse events | Other adverse events within 3 days after surgery were noted | Within 30 days after surgery | |
Secondary | 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 |
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