Postoperative Cognitive DysfunctionRCCNCT01911195
Reconstructing Consciousness and Cognition
A study testing ISOFLURANE- Experimental Arm in people with Postoperative Cognitive Dysfunction, run by University of Michigan at 3 sites in United States.
Trial summary
Currently it is unknown how the human brain reorganizes its network organization to generate conscious experience and cognitive activity after a period of unconsciousness. Therefore, the purpose of this study is to assess how cognitive activity is reconstructed after general anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- ISOFLURANE- Experimental Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2013to 9 Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy 20-40 year old volunteers,
- American Society of Anesthesiologists Physical Status I or II (i.e., healthy),
- Body mass index < 30 kg/m2,
- Easily visualized uvula,
- With anticipated equal recruitment of males and females.
Who cannot join
- Physical signs suggestive of difficult airway (e.g., mouth opening <3cm, short distance between the chin and neck, poor mandibular subluxation, thick neck),
- History of obstructive sleep apnea,
- Reactive airway disease,
- Neuropsychiatric disorders,
- History or current use of psychotropic medications,
- Current tobacco and alcohol use,
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- History of hypertension or current medication for blood pressure control, cardiovascular disease or arrhythmias,
- Positive urine toxicology screen,
- History of reflux,
- Pregnancy,
- Family history of problems with anesthesia (including but not limited to malignant hyperthermia),
- Sleep disorders,
- History of postoperative nausea/vomiting or motion sickness,
- Allergy to eggs, egg products or soy.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Currently it is unknown how the human brain reorganizes its network organization to generate conscious experience and cognitive activity after a period of unconsciousness. Therefore, the purpose of this study is to assess how cognitive activity is reconstructed after general anesthesia. The investigators hypothesize that the brain's transition from unconsciousness to consciousness and full cognition is a complex process that occurs over an extended period of time. Specifically, the investigators hypothesize the following order of cognitive reconstitution: responsiveness to command, attention, complex scanning and visual tracking, working memory, and executive function.
Volunteers will be healthy participants who are anesthetized with commonly used anesthetic drugs as well as a non-anesthetized group to control for circadian influences. A total of 60 subjects will be recruited for this study. All subjects (male and female) will perform basic tests for cognition on a laptop computer at 30-minute intervals during this study. The testing battery to be administered was assembled to assess multiple cognitive functions in order to determine whether and how cognitive processes return to baseline function. Electroencephalogram (measuring brain electrical activity) data will be monitored and recorded during both anesthesia and cognitive testing, for subsequent analysis.
This study is significant because it could lead to a better understanding of the neural correlates of human consciousness, as well as normal and abnormal conscious state transitions (including barriers to such transitions).
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- ISOFLURANE- Experimental Arm, Control Group: Cognitive Testing
- Keywords
- General anesthesia, cognition, consciousness
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISOFLURANE- Experimental ArmDrug
The experimental group will be given the anesthetic isoflurane for three hours, and will undergo cognitive tests immediately following emergence from general anesthesia while connected to an EEG machine.
Control Group: Cognitive TestingOther
The control group will undergo cognitive testing while connected to an EEG machine following a comparable rest period, but will not receive general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Control Group: Cognitive Testing | Active comparator | Control arm will receive cognitive testing only without undergoing general anesthesia Receives: Other: Control Group: Cognitive Testing |
| ISOFLURANE- Experimental Arm | Experimental | Experimental arm will receive cognitive testing before and after general anesthesia Receives: Drug: ISOFLURANE- Experimental Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive scores
Neurocognitive battery performed on computer
Measured: Three hours following emergence from general anesthesia
Secondary outcomes (1)
Brain network connectivity
Functional brain networks will be reconstructed from EEG data.
Measured: Three hours following emergence from general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJul 2013
- Primary completion9 Feb 2015
- Study completion9 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Washington University School of Medicine, James S McDonnell Foundation
- Responsible party
- Principal investigator, George Mashour, University of Michigan
- Investigators
- George A Mashour, MD, PhD, Principal investigator, University of MichiganMichael Avidan, MBBCh, Principal investigator, Washington University School of MedicineMax Kelz, MD, PhD, Principal investigator, University of PennsylvaniaMathias Basner, MD, PhD, MSc, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911195
- Sponsor's protocol ID
- McDonnell RCC
- Acronym
- RCC
- Status last verified
- Feb 2024
- First submitted
- 21 Jul 2013
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mashour GA, Palanca BJ, Basner M, Li D, Wang W, Blain-Moraes S, Lin N, Maier K, Muench M, Tarnal V, Vanini G, Ochroch EA, Hogg R, Schwartz M, Maybrier H, Hardie R, Janke E, Golmirzaie G, Picton P, McKinstry-Wu AR, Avidan MS, Kelz MB. Recovery of consciousness and cognition after general anesthesia in humans. Elife. 2021 May 10;10:e59525. doi: 10.7554/eLife.59525.
PubMed 33970101Labonte AK, Kafashan M, Huels ER, Blain-Moraes S, Basner M, Kelz MB, Mashour GA, Avidan MS, Palanca BJA; ReCCognition Study Group. The posterior dominant rhythm: an electroencephalographic biomarker for cognitive recovery after general anaesthesia. Br J Anaesth. 2023 Feb;130(2):e233-e242. doi: 10.1016/j.bja.2022.01.019. Epub 2022 Feb 17.
PubMed 35183346
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstructing Consciousness and Cognition
- ClinicalTrials.gov ID
- NCT01911195
- Acronym / sponsor ID
- RCC / McDonnell RCC
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- General anesthesia, cognition, consciousness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Washington University School of Medicine, James S McDonnell Foundation
- Study start
- Jul 2013 (actual)
- Primary completion
- 9 Feb 2015 (actual)
- Study completion
- 9 Feb 2015 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently it is unknown how the human brain reorganizes its network organization to generate conscious experience and cognitive activity after a period of unconsciousness. Therefore, the purpose of this study is to assess how cognitive activity is reconstructed after general anesthesia. The investigators hypothesize that the brain's transition from unconsciousness to consciousness and full cognition is a complex process that occurs over an extended period of time. Specifically, the investigators hypothesize the following order of cognitive reconstitution: responsiveness to command, attention, complex scanning and visual tracking, working memory, and executive function.
Volunteers will be healthy participants who are anesthetized with commonly used anesthetic drugs as well as a non-anesthetized group to control for circadian influences. A total of 60 subjects will be recruited for this study. All subjects (male and female) will perform basic tests for cognition on a laptop computer at 30-minute intervals during this study. The testing battery to be administered was assembled to assess multiple cognitive functions in order to determine whether and how cognitive processes return to baseline function. Electroencephalogram (measuring brain electrical activity) data will be monitored and recorded during both anesthesia and cognitive testing, for subsequent analysis.
This study is significant because it could lead to a better understanding of the neural correlates of human consciousness, as well as normal and abnormal conscious state transitions (including barriers to such transitions).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group: Cognitive Testing | Active comparator | Other: Control Group: Cognitive TestingControl arm will receive cognitive testing only without undergoing general anesthesia |
| ISOFLURANE- Experimental Arm | Experimental | Drug: ISOFLURANE- Experimental ArmExperimental arm will receive cognitive testing before and after general anesthesia |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy 20-40 year old volunteers,
- American Society of Anesthesiologists Physical Status I or II (i.e., healthy),
- Body mass index < 30 kg/m2,
- Easily visualized uvula,
- With anticipated equal recruitment of males and females.
Key exclusion criteria (14 listed)
- Physical signs suggestive of difficult airway (e.g., mouth opening <3cm, short distance between the chin and neck, poor mandibular subluxation, thick neck),
- History of obstructive sleep apnea,
- Reactive airway disease,
- Neuropsychiatric disorders,
- History or current use of psychotropic medications,
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 |
|---|---|---|
| ISOFLURANE- Experimental ArmThe experimental group will be given the anesthetic isoflurane for three hours, and will undergo cognitive tests immediately following emergence from general anesthesia while connected to an EEG machine. | Drug | ISOFLURANE- Experimental Arm |
| Control Group: Cognitive TestingThe control group will undergo cognitive testing while connected to an EEG machine following a comparable rest period, but will not receive general anesthesia. | Other | Control Group: Cognitive Testing |
Primary outcome
Neurocognitive scores
Time frame: Three hours following emergence from general anesthesia
Neurocognitive battery performed on computer
1 secondary outcome
Brain network connectivity
Time frame: Three hours following emergence from general anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 33970101Mashour GA, Palanca BJ, Basner M, Li D, Wang W, Blain-Moraes S, Lin N, Maier K, Muench M, Tarnal V, Vanini G, Ochroch EA, Hogg R, Schwartz M, Maybrier H, Hardie R, Janke E, Golmirzaie G, Picton P, McKinstry-Wu AR, Avidan MS, Kelz MB. Recovery of consciousness and cognition after general anesthesia in humans. Elife. 2021 May 10;10:e59525. doi: 10.7554/eLife.59525.
- Derived from this study: PubMed 35183346Labonte AK, Kafashan M, Huels ER, Blain-Moraes S, Basner M, Kelz MB, Mashour GA, Avidan MS, Palanca BJA; ReCCognition Study Group. The posterior dominant rhythm: an electroencephalographic biomarker for cognitive recovery after general anaesthesia. Br J Anaesth. 2023 Feb;130(2):e233-e242. doi: 10.1016/j.bja.2022.01.019. Epub 2022 Feb 17.
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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.
George A Mashour, MD, PhD principal investigator
University of Michigan
Michael Avidan, MBBCh principal investigator
Washington University School of Medicine
Max Kelz, MD, PhD principal investigator
University of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ISOFLURANE- Experimental Arm in people with Postoperative Cognitive Dysfunction, run by University of Michigan at 3 sites 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 5 inclusion and 14 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Neurocognitive scores (time frame: Three hours following emergence from general anesthesia). 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 NCT01911195, which also lists 2 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 20 Feb 2024; AzTrials last refreshed its copy on 28 Oct 2026.