N/A N=104 Supportive Care

Trajectory of Recovery in the Elderly

Delayed Emergence From Anesthesia · Postoperative Delirium · Postoperative Cognitive Dysfunction

Bottom Line

View on ClinicalTrials.gov: NCT02275026 ↗

Enrolled (actual)

104

Serious AEs

0.0%

Results posted

Jun 2021

Primary outcome: Primary: Number of Participants Recovered on Postoperative Quality of Recovery Scale (PQRS) — 3; 5; 1; 3 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Functional magnetic resonance imaging (Procedure)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Icahn School of Medicine at Mount Sinai
Primary completion: Apr 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Recovered on Postoperative Quality of Recovery Scale (PQRS)	3; 5; 1; 3; 8; 11	—
SECONDARY Change in NIH Tool Box Composite	48.1; 53.3; 50.1; 54; 52.2; 57.2	—

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.

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

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Data sourced from ClinicalTrials.gov (NCT02275026). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.