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Trajectory of Recovery in the Elderly (TORIE)

Primary Purpose

Delayed Emergence From Anesthesia, Postoperative Delirium, Postoperative Cognitive Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Functional magnetic resonance imaging
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Delayed Emergence From Anesthesia focused on measuring General Anesthesia, Postoperative Delirium, Recovery

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 > 30
  • Patients with significant metal implants in body
  • Current use of cocaine or opiates
  • Current smokers

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Functional magnetic resonance imaging

Arm Description

Magnetic resonance images will be acquired on a 3 Tesla scanner (Skyra, Siemens, Erlangen, Germany) with a 20 channel receiver coil.

Outcomes

Primary Outcome Measures

Number of Participants Recovered on Postoperative Quality of Recovery Scale (PQRS)
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. It is scored as recovered / not recovered based on level of performance, within a certain tolerance range, relative to preoperative (baseline) performance - before the general anesthesia / MRI scanning session. Postoperative Quality of Recovery Cognitive Scale at each study timepoint by age decade. Postoperative Quality of Recovery Cognitive

Secondary Outcome Measures

Change in NIH Tool Box Composite
NIH Toolbox Cognitive Battery is a multidimensional set of brief measures assessing cognitive (as well as emotional, motor and sensory) function. There is no score range, but mean score is 100 with standard deviation 15. A score at or near 100 indicates average ability compared with others. Scores around 115 suggest above-average ability. Scores around 130 suggest superior ability (in the top 2 percent nationally). A score around 85 suggests below-average ability. A score in the range of 70 or below suggests significant impairment.

Full Information

First Posted
October 23, 2014
Last Updated
May 19, 2021
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Aging (NIA), Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT02275026
Brief Title
Trajectory of Recovery in the Elderly
Acronym
TORIE
Official Title
Trajectory of Recovery in the Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
April 22, 2020 (Actual)
Study Completion Date
April 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute on Aging (NIA), Yale University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Emergence From Anesthesia, Postoperative Delirium, Postoperative Cognitive Dysfunction
Keywords
General Anesthesia, Postoperative Delirium, Recovery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Functional magnetic resonance imaging
Arm Type
Experimental
Arm Description
Magnetic resonance images will be acquired on a 3 Tesla scanner (Skyra, Siemens, Erlangen, Germany) with a 20 channel receiver coil.
Intervention Type
Procedure
Intervention Name(s)
Functional magnetic resonance imaging
Other Intervention Name(s)
fMRI
Intervention Description
Diffusion tensor imaging
Primary Outcome Measure Information:
Title
Number of Participants Recovered on Postoperative Quality of Recovery Scale (PQRS)
Description
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. It is scored as recovered / not recovered based on level of performance, within a certain tolerance range, relative to preoperative (baseline) performance - before the general anesthesia / MRI scanning session. Postoperative Quality of Recovery Cognitive Scale at each study timepoint by age decade. Postoperative Quality of Recovery Cognitive
Time Frame
15 min, 60 min, 1 day, 3 days, 7 days, 30 days, 6 months
Secondary Outcome Measure Information:
Title
Change in NIH Tool Box Composite
Description
NIH Toolbox Cognitive Battery is a multidimensional set of brief measures assessing cognitive (as well as emotional, motor and sensory) function. There is no score range, but mean score is 100 with standard deviation 15. A score at or near 100 indicates average ability compared with others. Scores around 115 suggest above-average ability. Scores around 130 suggest superior ability (in the top 2 percent nationally). A score around 85 suggests below-average ability. A score in the range of 70 or below suggests significant impairment.
Time Frame
Baseline, 1 day, 7 days, 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 > 30 Patients with significant metal implants in body Current use of cocaine or opiates Current smokers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Mincer, MD, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34889804
Citation
Baxter MG, Mincer JS, Brallier JW, Schwartz A, Ahn H, Nir T, McCormick PJ, Ismail M, Sewell M, Allore HG, Ramsey CM, Sano M, Deiner SG. Cognitive Recovery by Decade in Healthy 40- to 80-Year-Old Volunteers After Anesthesia Without Surgery. Anesth Analg. 2022 Feb 1;134(2):389-399. doi: 10.1213/ANE.0000000000005824.
Results Reference
derived
PubMed Identifier
34802696
Citation
Nir T, Raizman R, Meningher I, Jacob Y, Huang KH, Schwartz AE, Brallier JW, Ahn H, Kundu P, Tang CY, Delman BN, McCormick PJ, Scarpa J, Sano M, Deiner SG, Livny A, Baxter MG, Mincer JS. Lateralisation of subcortical functional connectivity during and after general anaesthesia. Br J Anaesth. 2022 Jan;128(1):65-76. doi: 10.1016/j.bja.2021.08.033. Epub 2021 Nov 19.
Results Reference
derived
PubMed Identifier
32800503
Citation
Nir T, Jacob Y, Huang KH, Schwartz AE, Brallier JW, Ahn H, Kundu P, Tang CY, Delman BN, McCormick PJ, Sano M, Deiner S, Baxter MG, Mincer JS. Resting-state functional connectivity in early postanaesthesia recovery is characterised by globally reduced anticorrelations. Br J Anaesth. 2020 Oct;125(4):529-538. doi: 10.1016/j.bja.2020.06.058. Epub 2020 Aug 14.
Results Reference
derived
PubMed Identifier
32536445
Citation
Deiner S, Baxter MG, Mincer JS, Sano M, Hall J, Mohammed I, O'Bryant S, Zetterberg H, Blennow K, Eckenhoff R. Human plasma biomarker responses to inhalational general anaesthesia without surgery. Br J Anaesth. 2020 Sep;125(3):282-290. doi: 10.1016/j.bja.2020.04.085. Epub 2020 Jun 11.
Results Reference
derived
PubMed Identifier
28891911
Citation
Mincer JS, Baxter MG, McCormick PJ, Sano M, Schwartz AE, Brallier JW, Allore HG, Delman BN, Sewell MC, Kundu P, Tang CY, Sanchez A, Deiner SG. Delineating the Trajectory of Cognitive Recovery From General Anesthesia in Older Adults: Design and Rationale of the TORIE (Trajectory of Recovery in the Elderly) Project. Anesth Analg. 2018 May;126(5):1675-1683. doi: 10.1213/ANE.0000000000002427.
Results Reference
derived

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Trajectory of Recovery in the Elderly

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