Delayed Emergence From AnesthesiaTORIENCT02275026
Trajectory of Recovery in the Elderly
A study testing Functional magnetic resonance imaging in people with Delayed Emergence From Anesthesia and Postoperative Delirium, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Delayed Emergence From Anesthesia, Postoperative Delirium, Postoperative Cognitive Dysfunction
- What is being tested?
- Functional magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 22 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
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.
Read the 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.
- Conditions
- Delayed Emergence From Anesthesia, Postoperative Delirium, Postoperative Cognitive Dysfunction
- Being tested
- Functional magnetic resonance imaging
- Keywords
- General Anesthesia, Postoperative Delirium, Recovery
- Medical subject headings
- Delayed Emergence from Anesthesia, Emergence Delirium, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional magnetic resonance imagingProcedure or surgery
Also called fMRI
Diffusion tensor imaging
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Functional magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 min, 60 min, 1 day, 3 days, 7 days, 30 days, 6 months
Secondary outcomes (1)
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.
Measured: Baseline, 1 day, 7 days, 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startJul 2015
- Primary completion22 Apr 2020
- Study completion22 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Delayed Emergence From AnesthesiaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Yale University
- Responsible party
- Principal investigator, Joshua Mincer, Icahn School of Medicine at Mount Sinai
- Investigators
- Joshua Mincer, MD, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275026
- Sponsor's protocol ID
- GCO 13-0359
- Other IDs
- 1R01AG046634
- Acronym
- TORIE
- Status last verified
- May 2021
- First submitted
- 23 Oct 2014
- Last updated
- 15 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 34889804Nir 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.
PubMed 34802696Nir 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.
PubMed 32800503Deiner 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.
PubMed 32536445Mincer 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.
PubMed 28891911
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trajectory of Recovery in the Elderly
- ClinicalTrials.gov ID
- NCT02275026
- Acronym / sponsor ID
- TORIE / GCO 13-0359
- Conditions
- Delayed Emergence From Anesthesia, Postoperative Delirium, Postoperative Cognitive Dysfunction
- Keywords
- General Anesthesia, Postoperative Delirium, Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Yale University
- Study start
- Jul 2015
- Primary completion
- 22 Apr 2020 (actual)
- Study completion
- 22 Apr 2020 (actual)
- First posted
- 27 Oct 2014 (estimated)
- Results
- Posted 15 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional magnetic resonance imaging | Experimental | Procedure: Functional magnetic resonance imagingMagnetic resonance images will be acquired on a 3 Tesla scanner (Skyra, Siemens, Erlangen, Germany) with a 20 channel receiver coil. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional magnetic resonance imagingAlso: fMRIDiffusion tensor imaging | Procedure or surgery | Functional magnetic resonance imaging |
Primary outcome
Number of Participants Recovered on Postoperative Quality of Recovery Scale (PQRS)
Time frame: 15 min, 60 min, 1 day, 3 days, 7 days, 30 days, 6 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. 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
1 secondary outcome
Change in NIH Tool Box Composite
Time frame: Baseline, 1 day, 7 days, 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34889804Baxter 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.
- Derived from this study: PubMed 34802696Nir 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.
- Derived from this study: PubMed 32800503Nir 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.
- Derived from this study: PubMed 32536445Deiner 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.
- Derived from this study: PubMed 28891911Mincer 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.
- Individual participant dataSharing planned: Undecided
Related trials for Delayed Emergence From Anesthesia
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Not yet recruitingObservational study
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Neuromuscular Blockade, Delayed Emergence From Anesthesia
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring in Adult NSICU Patients
Subarachnoid Hemorrhage, Aneurysmal, Brain Injuries, Traumatic
Not yet recruitingObservational study
Postoperative Residual Neuromuscular Block and Passive Smoke Exposure in Pediatric Dental Patients
Postoperative Residual Curarization, Neuromuscular Block Prolonged
Not yet recruitingObservational study
Acceleromyography Versus Electromyography for Neuromuscular Recovery Assessment at the End of Surgery
Neuromuscular Blockade, Cholecystectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Mincer, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional magnetic resonance imaging in people with Delayed Emergence From Anesthesia and Postoperative Delirium, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Recovered on Postoperative Quality of Recovery Scale (PQRS) (time frame: 15 min, 60 min, 1 day, 3 days, 7 days, 30 days, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02275026, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021.