Sevoflurane, Propofol and Desflurane on POD/POCD

Propofol Clinical Trial

Official title:

Effects of Anesthetics Sevoflurane, Propofol and Desflurane on Postoperative Delirium (POD) and Postoperative Cognitive Disorder (POCD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03326960
• Other study ID #: dsyy002
• Status: Recruiting
• Start date: January 1, 2016
• Est. completion date: June 30, 2021

Study information

• Verified date: October 2020
• Source: Shanghai 10th People's Hospital
• Contact: Yuan Shen, M.D.,Ph.D.
• Phone: 66303649
• Email: kmshy[@]tongji.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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-?

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

Related Conditions & MeSH terms

• Desflurane
• Propofol
• Sevoflurane

Intervention

Drug:
• Sevoflurane
Anesthesia maintenance with sevoflurane guided by Narcrotrend index monitoring.
• Propofol
Anesthesia maintenance with propofol guided by Narcrotrend index monitoring.
• Desflurane
Anesthesia maintenance with desflurane guided by Narcrotrend index monitoring.

Locations

Country	Name	City	State
China	Shanghai 10th People's Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital	Massachusetts General Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. Review. — View 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. — View Citation

Vlisides P, Xie Z. Neurotoxicity of general anesthetics: an update. Curr Pharm Des. 2012;18(38):6232-40. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative delirium	Postoperative delirium will be determined by Confusion Assessment Method (CAM) at 1st postoperative day	At 1st day after the surgery
Secondary	Postoperative delirium	Postoperative delirium will be determined by CAM at 2nd postoperative day	At 2nd day after the surgery
Secondary	Postoperative delirium	Postoperative delirium will be determined by CAM at 3rd postoperative day	At 3rd day after the surgery
Secondary	Preoperative cognitive function	Preoperative cognitive function will be assessed by neuropsychological battery	Preoperative cognitive function (baseline)
Secondary	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
Secondary	Postoperative cognitive dysfunction	Postoperative cognitive dysfunction will be assessed by neuropsychological battery	Change from baseline cognitive dysfunction at 3rd month
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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