Clinical trial NCT01911195: Reconstructing Consciousness and Cognition
Official title: Reconstructing Consciousness and Cognition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Cognitive Dysfunction
Keywords: General anesthesia
cognition
consciousness
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Washington University School of Medicine
name: James S McDonnell Foundation
First posted: 2013-07-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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. 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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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,
* 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.

Primary outcomes:
measure: Neurocognitive scores
timeFrame: Three hours following emergence from general anesthesia
Secondary outcomes:
measure: Brain network connectivity
timeFrame: Three hours following emergence from general anesthesia
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Michigan
name: George A Mashour, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Michael Avidan, MBBCh
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Max Kelz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Mathias Basner, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Labonte 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.