Reconstructing Consciousness and Cognition

Postoperative Cognitive Dysfunction Clinical Trial

— RCC  

Official title:

Reconstructing Consciousness and Cognition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01911195
• Other study ID #: McDonnell RCC
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: February 9, 2015

Study information

• Verified date: February 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 9, 2015
• Est. primary completion date: February 9, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction

Intervention

Drug:
• ISOFLURANE- 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.

Other:
• Control 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
University of Michigan	James S McDonnell Foundation, University of Pennsylvania, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurocognitive scores	Neurocognitive battery performed on computer	Three hours following emergence from general anesthesia
Secondary	Brain network connectivity	Functional brain networks will be reconstructed from EEG data.	Three hours following emergence from general anesthesia