ClinicalTrials.gov
ClinicalTrials.gov Menu

Trajectory of Recovery in the Elderly (TORIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02275026
Recruitment Status : Recruiting
First Posted : October 27, 2014
Last Update Posted : December 27, 2017
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Yale University
Information provided by (Responsible Party):
Joshua Mincer, Icahn School of Medicine at Mount Sinai

Brief Summary:
The purpose of this study is to understand how elderly individuals regain their cognitive skills following general anesthesia. The investigators will compare an age stratified group of volunteers who will be evaluated with a series of cognitive tests and a functional MRI. The participants will then be administered general anesthesia for two hours. The investigators will then assess the participants using state of the art tools to determine when participants return to their cognitive baseline.

Condition or disease Intervention/treatment Phase
Delayed Emergence From Anesthesia Postoperative Delirium Postoperative Cognitive Dysfunction Procedure: Functional magnetic resonance imaging Not Applicable

Detailed Description:
Elderly patients undergoing anesthesia and surgery frequently suffer from postoperative cognitive dysfunction (POCD) and postoperative delirium (PD). The cause of these entities is unknown. It is unclear what part anesthetics play in the development of POCD and PD. The investigators hypothesize that elderly patient's cognitive capacities recover more slowly after receiving general anesthesia, perhaps because they have more limited cognitive reserve. A more prolonged recovery would confound diagnoses of POCD and PD and potentially puts patients who are discharged on the day of surgery at risk of not understanding postoperative instructions. The trajectory of postoperative cognitive recovery has never been explored and elderly participants have been explicitly not included in any type of emergence research. To explore this vital area the investigators propose to study young and elderly volunteers with a combination of two state of the art neuropsychological tests (Postoperative Quality of Recovery Scale and the NIH Toolbox) and functional magnetic resonance imaging. Starting from baseline, the investigators will determine multiple cognitive domains and resting state networks, treat the participants with general anesthesia for two hours while continuing to examine network activity, and then explore the recovery of the cognitive domains and alterations in functional networks using both the PQRS and the NIH Toolbox Cognitive Measures. Participants will be evaluated at 1 month, 6 months, and 12 months.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Trajectory of Recovery in the Elderly
Study Start Date : July 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
Experimental: Functional magnetic resonance imaging
Magnetic resonance images will be acquired on a 3 Tesla scanner (Skyra, Siemens, Erlangen, Germany) with a 20 channel receiver coil.
Procedure: Functional magnetic resonance imaging
Diffusion tensor imaging
Other Name: fMRI




Primary Outcome Measures :
  1. Change in Postoperative Quality of Recovery Scale (PQRS) [ Time Frame: Baseline, 15 min, 40 min, 1 day, 3 days, 7 days, 30 days, 6 months, 12 months ]
    Cognitive Function using scales of the PQRS to test whether age is associated with the time of return to baseline cognitive function. The PQRS is a brief measurement tool to assess multiple domains of recovery, including cognition, over time.


Secondary Outcome Measures :
  1. Change in NIH Tool box assessment [ Time Frame: Baseline, 1 day, 7 days, 30 days ]
    NIH Toolbox Cognitive Battery is a multidimensional set of brief measures assessing cognitive (as well as emotional, motor and sensory) function.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 40-80 years old
  • American Society of Anesthesiologists (ASA) Physical Status I or II (i.e. Individuals with minimal disease burden)
  • Capable and willing to consent

Exclusion Criteria:

  • Airway assessment as potentially difficult (Mallampati III or greater)
  • Allergies or hypersensitivity to drug or class
  • Chronic Inflammatory conditions such a lupus or system rheumatoid arthritis (arthritis limited to 1 or 2 joints will be acceptable)
  • Patients with diabetes mellitus
  • Patients with a recent illness (within the last 2 weeks)
  • Patients with severe visual or auditory disorder/handicaps
  • English illiteracy
  • Pregnancy
  • Participants not expected to be able to complete the postoperative tests
  • History of malignant hyperthermia
  • Nursing mothers
  • Body Mass Index > 32
  • Patients with significant metal implants in body
  • Current use of cocaine or opiates
  • Current smokers

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): NCT02275026


Contacts
Contact: Kirklyn Escondo 212-241-4442 kirklyn.escondo@mountsinai.org
Contact: Rachelle Jacoby 212-241-7631 rachelle.jacoby@mountsinai.org

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Angela Sanchez    212-241-0840    angela.sanchez@mountsinai.org   
Principal Investigator: Joshua Mincer, MD, PhD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institute on Aging (NIA)
Yale University
Investigators
Principal Investigator: Joshua Mincer, MD, PhD Icahn School of Medicine at Mount Sinai

Responsible Party: Joshua Mincer, Assistant Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02275026     History of Changes
Other Study ID Numbers: GCO 13-0359
1R01AG046634 ( U.S. NIH Grant/Contract )
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Joshua Mincer, Icahn School of Medicine at Mount Sinai:
General Anesthesia, Postoperative Delirium, Recovery

Additional relevant MeSH terms:
Delirium
Cognitive Dysfunction
Delayed Emergence from Anesthesia
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Postoperative Complications
Pathologic Processes