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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG046634 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Yale University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional magnetic resonance imaging | Procedure | Diffusion tensor imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Mincer, MD, PhD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34889804 | Derived | 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. | |
| 34802696 | 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. |
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Recruitment was completed in May 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Functional Magnetic Resonance Imaging | Magnetic resonance images acquired on a 3 Tesla scanner (Skyra, Siemens, Erlangen, Germany) with a 20 channel receiver coil. Functional magnetic resonance imaging: Diffusion tensor imaging |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants who completed Day 1 Scan
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| ID | Title | Description |
|---|---|---|
| BG000 | Functional Magnetic Resonance Imaging | Magnetic resonance images acquired on a 3 Tesla scanner (Skyra, Siemens, Erlangen, Germany) with a 20 channel receiver coil. Functional magnetic resonance imaging: Diffusion tensor imaging |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Scale could not be determined for 2 participants (1 in the 40-49 year age decade, one in the 70-80 year age decade). | Posted | Count of Participants | Participants | 15 min, 60 min, 1 day, 3 days, 7 days, 30 days, 6 months |
|
30 days
According to Michigan Awareness Classification Instrument
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Functional Magnetic Resonance Imaging | Magnetic resonance images acquired on a 3 Tesla scanner (Skyra, Siemens, Erlangen, Germany) with a 20 channel receiver coil. Functional magnetic resonance imaging: Diffusion tensor imaging |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sore Throat | Injury, poisoning and procedural complications | MACI | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joshua Mincer | Icahn School of Medicine at Mount Sinai | (917) 922-9475 | joshua.mincer@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 23, 2018 | Apr 2, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 31, 2013 | Apr 2, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D055191 | Delayed Emergence from Anesthesia |
| D000071257 | Emergence Delirium |
| D000079690 | Postoperative Cognitive Complications |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003693 | Delirium |
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| Baseline, 1 day, 7 days, 30 days |
| 32800503 | 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. |
| 32536445 | 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. |
| 28891911 | 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. |
| MRI malfunction precluded testing |
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| Ineligible after MRI findings |
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| Lost to Follow-up |
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| Scanner failure |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index (BMI) | Median | Inter-Quartile Range | kg/m^2 |
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| ASA Physical Status | American Society of Anesthesiologists Physical Status Classification System. Classification 1- 6, higher score indicates poorer health outcomes. | Count of Participants | Participants |
|
| Disease History | Count of Participants | Participants |
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| Number of medications on initial assessment | Count of Participants | Participants |
|
Groups divided by age decade
| OG001 | Age Decade 50-59 | Groups divided by age decade |
| OG002 | Age Decade 60-69 | Groups divided by age decade |
| OG003 | Age Decade 70-80 | Groups divided by age decade |
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| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, 1 day, 7 days, 30 days |
|
|
|
| 0 |
| 72 |
| 0 |
| 72 |
| 4 |
| 72 |
| Nausea | Gastrointestinal disorders | MACI | Systematic Assessment |
|
| Eye discomfort | Eye disorders | MACI | Systematic Assessment |
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| Lingual nerve compression injury | Nervous system disorders | MACI | Systematic Assessment |
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| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D060825 | Cognitive Dysfunction |
| D003072 | Cognition Disorders |
| 1 day |
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| 7 days |
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| 30 days |
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