Sevoflurane, Propofol and Desflurane on POD/POCD

NCT03326960 | Unknown DMC

• 1 other identifier: dsyy002
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Sevoflurane; Propofol; Desflurane

Keywords

general anesthesia; postoperative delirium; postoperative cognitive dysfunction; retinal nerve fiber layer; biomarker

Outcome Measures

Primary Outcomes (1)

• Postoperative delirium

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

  At 1st day after the surgery

Secondary Outcomes (10)

• Postoperative delirium

  At 2nd day after the surgery

• Postoperative delirium

  At 3rd day after the surgery

• Preoperative cognitive function

  Preoperative cognitive function (baseline)

• Postoperative cognitive dysfunction

  Change from baseline cognitive dysfunction at 1 week

• Postoperative cognitive dysfunction

  Change from baseline cognitive dysfunction at 3rd month

Study Arms (3)

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

Propofol

Patients in Propofol group are maintained with propofol through intravenous administration guided by Narcrotrend index monitoring.

Drug: Propofol

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

Interventions

Sevoflurane DRUG

Anesthesia maintenance with sevoflurane guided by Narcrotrend index monitoring.

Sevoflurane

Propofol DRUG

Anesthesia maintenance with propofol guided by Narcrotrend index monitoring.

Propofol

Desflurane DRUG

Anesthesia maintenance with desflurane guided by Narcrotrend index monitoring.

Desflurane

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

Related Publications (5)

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

  PMID: 22762477 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.

  PMID: 20664045 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.

  PMID: 26352694 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.

  PMID: 23992774 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.

  PMID: 24088092 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Emergence Delirium; Postoperative Cognitive Complications

Interventions

Sevoflurane; Propofol; Desflurane

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognitive Dysfunction; Cognition Disorders

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Ethyl Ethers

Study Officials

• Yuan Shen, M.D.,Ph.D

  Shanghai 10th People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

66303649; kmshy@tongji.edu.cn

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

CONTACT

18701915271; szy0721@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Psychiatry

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: October 31, 2017
• Study Start: January 1, 2016
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

CN (1)