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Intraoperative EEG Marker of Preoperative Frailty in Elderly Patients

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ClinicalTrials.gov Identifier: NCT04783662
Recruitment Status : Recruiting
First Posted : March 5, 2021
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

Brief Summary:
Frailty is a state of vulnerability, characterized by a loss of mechanisms that maintain homeostasis, determining a lower capacity for recovery in the event of a stressful incident. It is one of the risk factors that increase postoperative adverse outcomes in the elderly population. It has been associated with worse results in different surgical settings, including increased mortality, readmission, referral to specialized care units, increased costs and hospital stay. Currently, there are several instruments for diagnosis and screening of frailty. All of them require time for their execution, an experienced evaluator and an adequate validation in the population in which they are intended to be used. The use of frontal electroencephalography during the intraoperative period has become increasingly popular. It allows the monitoring of brain activity during the administration of anesthetics. Various intraoperative electroencephalographic markers, such as alpha spectral power or total spectrum power, have been associated with factors such as preoperative physical activity, preoperative cognitive level, comorbidities, and postoperative delirium. The objective of this study will be to determine an intraoperative frontal electroencephalographic marker of preoperative frailty in ≥ 65 years patients undergoing general anesthesia with Sevoflurane for non-cardiac surgery.

Condition or disease Intervention/treatment
Frailty Device: Intraoperative frontal electroencephalogram

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of an Intraoperative Frontal Electroencephalographic Marker of Preoperative Frailty in Patients Over 65 Years of Age for Elective Non-cardiac Surgery.
Actual Study Start Date : May 13, 2021
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : April 1, 2022

Group/Cohort Intervention/treatment
Robust
Patients ≥65 years, undergoing elective non cardiac surgery which Fried phenotype score is equal to 0
Device: Intraoperative frontal electroencephalogram
Intra operative frontal electroencephalogram registration with 1 age adjusted Minimum Anesthetic Concentration of Sevoflurane

Pre Frail
Patients ≥65 years, undergoing elective non cardiac surgery which Fried phenotype score is 1 or 2
Device: Intraoperative frontal electroencephalogram
Intra operative frontal electroencephalogram registration with 1 age adjusted Minimum Anesthetic Concentration of Sevoflurane

Frail
Patients ≥65 years, undergoing elective non cardiac surgery which Fried phenotype score is equal or greater than 3
Device: Intraoperative frontal electroencephalogram
Intra operative frontal electroencephalogram registration with 1 age adjusted Minimum Anesthetic Concentration of Sevoflurane




Primary Outcome Measures :
  1. Electroencephalogram Alpha power [ Time Frame: 10 minutes after airway intubation ]
    Frontal electroencephalogram spectral power between 8 - 12 Hz


Secondary Outcome Measures :
  1. Electroencephalogram Total power [ Time Frame: 10 minutes after airway intubation ]
    Frontal electroencephalogram spectral power between 0.1 - 35 Hz

  2. Fried Phenotype [ Time Frame: During preoperative anesthetic visit ]
    Frailty assessed with the Fried Phenotype, minimum value: 1 - maximum value: 5, higher scores meaning worse outcomes.

  3. FRAIL scale [ Time Frame: During preoperative anesthetic visit ]
    Frailty assessed with the FRAIL Scale, minimum value: 1 - maximum value: 5, higher scores meaning worse outcomes.

  4. Clinical Frailty Scale (CFS) [ Time Frame: During preoperative anesthetic visit ]
    Frailty assessed with CFS, minimum value: 1(Very fit) - maximum value: 9 (Terminally ill), higher scores meaning worse outcomes.

  5. MiniCog test [ Time Frame: During preoperative anesthetic visit ]
    Screening for cognitive impairment, minimum value: 0 - maximum value: 5, higher scores meaning better outcomes

  6. MOCA (Montreal Cognitive Assessment) test [ Time Frame: During preoperative anesthetic visit, if MiniCog is positive for cognitive impairment ]
    Cognitive evaluation using MOCA (Montreal Cognitive Assessment) test, if MiniCog is positive for cognitive impairment (MiniCog ≤ 2). Minimum value: 0 - maximum value: 30, higher scores meaning better outcomes

  7. Post Anesthesia Care Unit (PACU) Postoperative Delirium [ Time Frame: One hour after patient is admitted to PACU ]
    Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), positive or negative



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Ages Eligible for Study:   65 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients ≥ 65 years scheduled for elective non-cardiac surgery requiring general anesthesia.
Criteria

Inclusion Criteria:

  • Patients ≥ 65 years of age
  • Undergoing elective non-cardiac surgery requiring general anesthesia with Sevoflurane
  • American Society of Anesthesiologists Physical Status I to III

Exclusion Criteria:

  • Emergency surgery
  • Neurosurgical patients
  • History of alcohol
  • History of recreational psychoactive drug use
  • Allergy to anesthetic drugs.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04783662


Contacts
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Contact: Juan C Pedemonte, MD +56223543270 jcpedemo@uc.cl
Contact: Victor Contreras, RN +56223543270 vecontre@uc.cl

Locations
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Chile
Hospital Clínico Pontificia Universidad Católica de Chile Recruiting
Santiago, Región Metropolitana, Chile, 8330024
Contact: Juan C Pedemonte, MD    223543270    jcpedemo@uc.cl   
Contact: Victor Contreras, RN    223543270    vecontre@uc.cl   
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
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Principal Investigator: Juan C Pedemonte, MD Pontificia Universidad Catolica de Chile
  Study Documents (Full-Text)

Documents provided by Pontificia Universidad Catolica de Chile:
Statistical Analysis Plan  [PDF] January 14, 2021
Informed Consent Form  [PDF] January 14, 2021

Publications:

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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT04783662    
Other Study ID Numbers: 200927001
First Posted: March 5, 2021    Key Record Dates
Last Update Posted: May 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: All data will be collected and saved in digital forms. Data may be shared with other researchers with previous authorization from the PI.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pontificia Universidad Catolica de Chile:
Frailty
Electroencephalography
Pre operative
Alpha power
Additional relevant MeSH terms:
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Frailty
Pathologic Processes