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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevoflurane | Patients in Sevoflurane group are maintained with sevoflurane from an anesthesia machine through the laryngeal mask airway guided by Narcrotrend index monitoring. |
| |
| Propofol | Patients in Propofol group are maintained with propofol through intravenous administration 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevoflurane | Drug | Anesthesia maintenance with sevoflurane guided by Narcrotrend index monitoring. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative delirium | Postoperative delirium will be determined by Confusion Assessment Method (CAM) at 1st postoperative day | At 1st day after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative delirium | Postoperative delirium will be determined by CAM at 2nd postoperative day | At 2nd day after the surgery |
| Postoperative delirium | Postoperative delirium will be determined by CAM at 3rd postoperative day |
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Inclusion Criteria:
Exclusion Criteria:
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Patients, aged 60 years old or older, who admitted to the Department of Orthopedics at Shanghai 10th People's Hospital and had been scheduled to undergo knee or hip fractures were screened and asked to participate in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuan Shen, M.D.,Ph.D. | Contact | 66303649 | kmshy@tongji.edu.cn | |
| Zhongyong Shi, M.D., Ph.D. | Contact | 18701915271 | szy0721@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuan Shen, M.D.,Ph.D | Shanghai 10th People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai 10th People's Hospital | Recruiting | Shanghai | Shanghai Municipality | 200072 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22762477 | Background | Vlisides P, Xie Z. Neurotoxicity of general anesthetics: an update. Curr Pharm Des. 2012;18(38):6232-40. doi: 10.2174/138161212803832344. | |
| 20664045 | Background | Witlox J, Eurelings LS, de Jonghe JF, Kalisvaart KJ, Eikelenboom P, van Gool WA. Delirium in elderly patients and the risk of postdischarge mortality, institutionalization, and dementia: a meta-analysis. JAMA. 2010 Jul 28;304(4):443-51. doi: 10.1001/jama.2010.1013. |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D000079690 | Postoperative Cognitive Complications |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000077149 | Sevoflurane |
| D015742 | Propofol |
| D000077335 | Desflurane |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
Not provided
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The investigators will collect 10ml venous blood before anesthesia, and then 10ml venous blood after surgery on Day 1, Day 2 and Day 3, respectively. Serum level of vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s) will be tested.
| Propofol | Drug | Anesthesia maintenance with propofol guided by Narcrotrend index monitoring. |
|
| Desflurane | Drug | Anesthesia maintenance with desflurane guided by Narcrotrend index monitoring. |
|
| At 3rd day after the surgery |
| Preoperative cognitive function | Preoperative cognitive function will be assessed by neuropsychological battery | Preoperative cognitive function (baseline) |
| Postoperative cognitive dysfunction | Postoperative cognitive dysfunction will be assessed by neuropsychological battery before and after the surgery and anesthesia | Change from baseline cognitive dysfunction at 1 week |
| Postoperative cognitive dysfunction | Postoperative cognitive dysfunction will be assessed by neuropsychological battery | Change from baseline cognitive dysfunction at 3rd month |
| Retinal nerve fiber layer thickness | Retinal nerve fiberlayer(RNFL)thickness will be measured by optical coherence tomography (OCT) before and after surgery and anesthesia | Change from baseline RNFL thickness at 3rd month |
| Serum level of vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s) | vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s) will be tested | Before the surgery (baseline) |
| Serum level of vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s) | vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s) will be tested | At 1st day after the surgery |
| Serum level of vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s) | vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s) will be tested | At 2nd day after the surgery |
| Serum level of vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s) | vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s) will be tested | At 3rd day after the surgery |
| 26352694 | Background | Gleason LJ, Schmitt EM, Kosar CM, Tabloski P, Saczynski JS, Robinson T, Cooper Z, Rogers SO Jr, Jones RN, Marcantonio ER, Inouye SK. Effect of Delirium and Other Major Complications on Outcomes After Elective Surgery in Older Adults. JAMA Surg. 2015 Dec;150(12):1134-40. doi: 10.1001/jamasurg.2015.2606. |
| 23992774 | Background | Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28. |
| 24088092 | Background | Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372. |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D060825 | Cognitive Dysfunction |
| D003072 | Cognition Disorders |
| D006846 |
| Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D005019 | Ethyl Ethers |