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Reconstructing Consciousness and Cognition

Reconstructing Consciousness and Cognition

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01911195
Acronym
RCC
Enrollment
60
Registered
2013-07-30
Start date
2013-07-31
Completion date
2015-02-09
Last updated
2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Cognitive Dysfunction

Keywords

General anesthesia, cognition, consciousness

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).

Interventions

DRUGISOFLURANE- Experimental Arm

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.

OTHERControl Group: Cognitive Testing

The control group will undergo cognitive testing while connected to an EEG machine following a comparable rest period, but will not receive general anesthesia.

Sponsors

University of Pennsylvania
CollaboratorOTHER
Washington University School of Medicine
CollaboratorOTHER
James S McDonnell Foundation
CollaboratorOTHER
University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Neurocognitive scoresThree hours following emergence from general anesthesiaNeurocognitive battery performed on computer

Secondary

MeasureTime frameDescription
Brain network connectivityThree hours following emergence from general anesthesiaFunctional brain networks will be reconstructed from EEG data.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026