Clinical trial NCT03326960: Sevoflurane, Propofol and Desflurane on POD/POCD
Official title: Effects of Anesthetics Sevoflurane, Propofol and Desflurane on Postoperative Delirium (POD) and Postoperative Cognitive Disorder (POCD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sevoflurane
Propofol
Desflurane
Keywords: general anesthesia
postoperative delirium
postoperative cognitive dysfunction
retinal nerve fiber layer
biomarker
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2017-10-31
Enrollment: 300
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Postoperative delirium
timeFrame: At 1st day after the surgery
Secondary outcomes:
measure: Postoperative delirium
timeFrame: At 2nd day after the surgery
measure: Postoperative delirium
timeFrame: At 3rd day after the surgery
measure: Preoperative cognitive function
timeFrame: Preoperative cognitive function (baseline)
measure: Postoperative cognitive dysfunction
timeFrame: Change from baseline cognitive dysfunction at 1 week
measure: Postoperative cognitive dysfunction
timeFrame: Change from baseline cognitive dysfunction at 3rd month
measure: Retinal nerve fiber layer thickness
timeFrame: Change from baseline RNFL thickness at 3rd month
measure: Serum level of vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s)
timeFrame: Before the surgery (baseline)
measure: Serum level of vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s)
timeFrame: At 1st day after the surgery
measure: Serum level of vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s)
timeFrame: At 2nd day after the surgery
measure: Serum level of vitamin B12, folic acid, homocysteine and myeloid differentiation protein-2 (MD-2s)
timeFrame: At 3rd day after the surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 10th People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Yuan Shen, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.