Trajectory of Recovery in the Elderly

NCT02275026 | Completed Results DMC

• 2 other identifiers: GCO 13-03591R01AG046634
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Delayed Emergence From Anesthesia; Postoperative Delirium; Postoperative Cognitive Dysfunction

Keywords

General Anesthesia, Postoperative Delirium, Recovery

Outcome Measures

Primary Outcomes (1)

• 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

  15 min, 60 min, 1 day, 3 days, 7 days, 30 days, 6 months

Secondary Outcomes (1)

• Change in NIH Tool Box Composite

  Baseline, 1 day, 7 days, 30 days

Study Arms (1)

Functional magnetic resonance imaging

EXPERIMENTAL

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

Interventions

Functional magnetic resonance imaging PROCEDURE

Diffusion tensor imaging

Also known as: fMRI

Functional magnetic resonance imaging

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute on Aging (NIA): collaborator
• Yale University: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (5)

• 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.

  PMID: 34889804 DERIVED

• 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.

  PMID: 34802696 DERIVED

• 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.

  PMID: 32800503 DERIVED

• 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.

  PMID: 32536445 DERIVED

• 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.

  PMID: 28891911 DERIVED

MeSH Terms

Conditions

Delayed Emergence from Anesthesia; Emergence Delirium; Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Joshua Mincer
• Organization: Icahn School of Medicine at Mount Sinai

joshua.mincer@mountsinai.org

(917) 922-9475

Study Officials

• Joshua Mincer, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: October 27, 2014
• Study Start: July 1, 2015
• Primary Completion: April 22, 2020
• Study Completion: April 22, 2020
• Last Updated: June 15, 2021
• Results First Posted: June 15, 2021

Record last verified: 2021-05

Locations

US (1)