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Sevoflurane, Propofol and Desflurane on POD/POCD

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ToestandWerving
Sponsors
Shanghai 10th People's Hospital
Medewerkers
Massachusetts General Hospital

Sleutelwoorden

Abstract

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.

Omschrijving

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.

Datums

Laatst geverifieerd: 04/30/2019
Eerste ingediend: 10/05/2017
Geschatte inschrijving ingediend: 10/29/2017
Eerst geplaatst: 10/30/2017
Laatste update ingediend: 05/26/2019
Laatste update geplaatst: 05/28/2019
Werkelijke startdatum van het onderzoek: 12/31/2015
Geschatte primaire voltooiingsdatum: 06/29/2021
Geschatte voltooiingsdatum van het onderzoek: 06/29/2021

Conditie of ziekte

Sevoflurane
Propofol
Desflurane

Interventie / behandeling

Drug: Sevoflurane

Drug: Propofol

Drug: Desflurane

Fase

-

Armgroepen

ArmInterventie / behandeling
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.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie 60 Years Naar 60 Years
Geslachten die in aanmerking komen voor studieAll
BemonsteringsmethodeNon-Probability Sample
Accepteert gezonde vrijwilligersJa
Criteria

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

Resultaat

Primaire uitkomstmaten

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

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

Secundaire uitkomstmaten

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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