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Sevoflurane, Propofol and Desflurane on POD/POCD

Csak regisztrált felhasználók fordíthatnak cikkeket
Belépés Regisztrálás
A hivatkozás a vágólapra kerül
ÁllapotToborzás
Szponzorok
Shanghai 10th People's Hospital
Együttműködők
Massachusetts General Hospital

Kulcsszavak

Absztrakt

The investigators will perform clinical studies to test the hypothesis that participants who have total hip/knee replacement under sevoflurane, propofol or desflurane anesthesia will have different effects on the incidence and severity of POD/POCD, and POD/POCD is associated with retinal nerve fiber layer (RNFL) thickness, as well as Serum level of vitamin B12, folic acid, homocysteine and human myeloid differentiation protein-2 (MD-2s). The investigators plan to perform the studies in 300 participants at Shanghai 10th People's Hospital.

Leírás

Postoperative delirium (POD) and postoperative cognitive disorder (POCD) are the most common complications of geriatric surgical patients, which could cause long-term social dysfunction, high mortality and increased medical cost. Currently, there is no efficient biomarker for POD/POCD, and it also remains largely unknown whether different anesthesia might lead to different incidence and severity of POD/POCD. The investigator's previous studies showed that thickness of retinal nerve fiber layer thickness (RNFL-T) measured by optical coherence tomography (OCT) was associated with POD/POCD; change of RNFL thickness (RNFL-C) in certain period correlated with cognitive deterioration. Thus, the investigators consider that RNFL might be a potential biomarker of POD/POCD. In the proposed large-scale longitudinal studies, the investigators will clinically validate RNF-LT as pre-operative POD/POCD biomarker, and RNFL-C as post-operative biomarker of POD/POCD. Finally, the investigators will compare the effects of surgery (total hip/knee replacement) under general anesthesia with sevoflurane, propofol and desflurane on the incidence and severity of POD/POCD in patients. Results from the proposed studies will likely establish RNFL as a potential POD/POCD biomarker, promote the clinical utilization of OCT-RNFL in early screening and outcome prediction of POD/POCD, and finally optimize anesthesia care of geriatric surgical patients to avoid or reduce POD/POCD incidence. These findings will lead to better postoperative outcomes of geriatric patients.

Dátumok

Utolsó ellenőrzés: 04/30/2019
Első benyújtás: 10/05/2017
Becsült beiratkozás benyújtva: 10/29/2017
Első közzététel: 10/30/2017
Utolsó frissítés beküldve: 05/26/2019
Utolsó frissítés közzétéve: 05/28/2019
A tanulmány tényleges kezdési dátuma: 12/31/2015
Becsült elsődleges befejezési dátum: 06/29/2021
A tanulmány becsült befejezési dátuma: 06/29/2021

Állapot vagy betegség

Sevoflurane
Propofol
Desflurane

Beavatkozás / kezelés

Drug: Sevoflurane

Drug: Propofol

Drug: Desflurane

Fázis

-

Karcsoportok

KarBeavatkozás / kezelés
Sevoflurane
Patients in Sevoflurane group are maintained with sevoflurane from an anesthesia machine through the laryngeal mask airway guided by Narcrotrend index monitoring.
Drug: Sevoflurane
Anesthesia maintenance with sevoflurane guided by Narcrotrend index monitoring.
Propofol
Patients in Propofol group are maintained with propofol through intravenous administration guided by Narcrotrend index monitoring.
Drug: Propofol
Anesthesia maintenance with propofol guided by Narcrotrend index monitoring.
Desflurane
Patients in Desflurane group are maintained with desflurane from an anesthesia machine through the laryngeal mask airway guided by Narcrotrend index monitoring.
Drug: Desflurane
Anesthesia maintenance with desflurane guided by Narcrotrend index monitoring.

Jogosultsági kritériumok

Tanulásra alkalmas korok 60 Years Nak nek 60 Years
Tanulásra alkalmas nemekAll
Mintavételi módszerNon-Probability Sample
Egészséges önkénteseket fogadIgen
Kritériumok

Inclusion Criteria:

- 60 years old or older

- Chinese Mandarin as the native language

- scheduled to undergo hip/knee surgery under general anesthesia

- American Society of Anesthesiologists (ASA) class I-Ⅲ

Exclusion Criteria:

- Prior diagnoses of neurological diseases according to ICD-10

- History of severe psychiatric disorders according to DSM-IV

- Visual or auditory defects

- Participating in the investigation of another study

Eredmény

Elsődleges eredménymérők

1. Postoperative delirium [At 1st day after the surgery]

Postoperative delirium will be determined by Confusion Assessment Method (CAM) at 1st postoperative day

Másodlagos eredménymérők

1. Postoperative delirium [At 2nd day after the surgery]

Postoperative delirium will be determined by CAM at 2nd postoperative day

2. Postoperative delirium [At 3rd day after the surgery]

Postoperative delirium will be determined by CAM at 3rd postoperative day

3. Preoperative cognitive function [Preoperative cognitive function (baseline)]

Preoperative cognitive function will be assessed by neuropsychological battery

4. Postoperative cognitive dysfunction [Change from baseline cognitive dysfunction at 1 week]

Postoperative cognitive dysfunction will be assessed by neuropsychological battery before and after the surgery and anesthesia

5. Postoperative cognitive dysfunction [Change from baseline cognitive dysfunction at 3rd month]

Postoperative cognitive dysfunction will be assessed by neuropsychological battery

6. Retinal nerve fiber layer thickness [Change from baseline RNFL thickness at 3rd month]

Retinal nerve fiberlayer(RNFL)thickness will be measured by optical coherence tomography (OCT) before and after surgery and anesthesia

7. Serum level of vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s) [Before the surgery (baseline)]

vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s) will be tested

8. Serum level of vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s) [At 1st day after the surgery]

vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s) will be tested

9. Serum level of vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s) [At 2nd day after the surgery]

vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s) will be tested

10. Serum level of vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s) [At 3rd day after the surgery]

vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s) will be tested

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