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Reconstructing Consciousness and Cognition (RCC)

Primary Purpose

Postoperative Cognitive Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ISOFLURANE- Experimental Arm
Control Group: Cognitive Testing
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Postoperative Cognitive Dysfunction focused on measuring General anesthesia, cognition, consciousness

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Michigan
  • Washington University in St. Louis
  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group: Cognitive Testing

ISOFLURANE- Experimental Arm

Arm Description

Control arm will receive cognitive testing only without undergoing general anesthesia

Experimental arm will receive cognitive testing before and after general anesthesia

Outcomes

Primary Outcome Measures

Neurocognitive scores
Neurocognitive battery performed on computer

Secondary Outcome Measures

Brain network connectivity
Functional brain networks will be reconstructed from EEG data.

Full Information

First Posted
July 21, 2013
Last Updated
November 28, 2017
Sponsor
University of Michigan
Collaborators
University of Pennsylvania, Washington University School of Medicine, James S McDonnell Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01911195
Brief Title
Reconstructing Consciousness and Cognition
Acronym
RCC
Official Title
Reconstructing Consciousness and Cognition
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (Actual)
Primary Completion Date
February 9, 2015 (Actual)
Study Completion Date
February 9, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
University of Pennsylvania, Washington University School of Medicine, James S McDonnell Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cognitive Dysfunction
Keywords
General anesthesia, cognition, consciousness

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group: Cognitive Testing
Arm Type
Active Comparator
Arm Description
Control arm will receive cognitive testing only without undergoing general anesthesia
Arm Title
ISOFLURANE- Experimental Arm
Arm Type
Experimental
Arm Description
Experimental arm will receive cognitive testing before and after general anesthesia
Intervention Type
Drug
Intervention Name(s)
ISOFLURANE- Experimental Arm
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group: Cognitive Testing
Intervention Description
The control group will undergo cognitive testing while connected to an EEG machine following a comparable rest period, but will not receive general anesthesia.
Primary Outcome Measure Information:
Title
Neurocognitive scores
Description
Neurocognitive battery performed on computer
Time Frame
Three hours following emergence from general anesthesia
Secondary Outcome Measure Information:
Title
Brain network connectivity
Description
Functional brain networks will be reconstructed from EEG data.
Time Frame
Three hours following emergence from general anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George A Mashour, MD, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Avidan, MBBCh
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Max Kelz, MD, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mathias Basner, MD, PhD, MSc
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35183346
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.
Results Reference
derived
PubMed Identifier
33970101
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.
Results Reference
derived

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Reconstructing Consciousness and Cognition

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