Sevoflurane, Propofol and Desflurane on POD/POCD

NCT ID: NCT03326960

Last Updated: 2020-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sevoflurane Propofol Desflurane

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sevoflurane

Patients in Sevoflurane group are maintained with sevoflurane from an anesthesia machine through the laryngeal mask airway guided by Narcrotrend index monitoring.

Sevoflurane

Intervention Type DRUG

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.

Propofol

Intervention Type DRUG

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.

Desflurane

Intervention Type DRUG

Anesthesia maintenance with desflurane guided by Narcrotrend index monitoring.

Interventions

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Sevoflurane

Anesthesia maintenance with sevoflurane guided by Narcrotrend index monitoring.

Intervention Type DRUG

Propofol

Anesthesia maintenance with propofol guided by Narcrotrend index monitoring.

Intervention Type DRUG

Desflurane

Anesthesia maintenance with desflurane guided by Narcrotrend index monitoring.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yuan Shen, MD, PhD

Head of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuan Shen, M.D.,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Shanghai 10th People's Hospital

Locations

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Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuan Shen, M.D.,Ph.D.

Role: CONTACT

Zhongyong Shi, M.D., Ph.D.

Role: CONTACT

18701915271

Facility Contacts

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Yanxia Guo, M.D.

Role: primary

021-65982875

References

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Vlisides P, Xie Z. Neurotoxicity of general anesthetics: an update. Curr Pharm Des. 2012;18(38):6232-40. doi: 10.2174/138161212803832344.

Reference Type BACKGROUND
PMID: 22762477 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20664045 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26352694 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23992774 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24088092 (View on PubMed)

Other Identifiers

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dsyy002

Identifier Type: -

Identifier Source: org_study_id

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