Reconstructing Consciousness and Cognition

NCT ID: NCT01911195

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-02-09

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).

Conditions

Postoperative Cognitive Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Control Group: Cognitive Testing

Control arm will receive cognitive testing only without undergoing general anesthesia

Group Type: ACTIVE_COMPARATOR

Control Group: Cognitive Testing

Intervention Type: OTHER

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

ISOFLURANE- Experimental Arm

Experimental arm will receive cognitive testing before and after general anesthesia

Group Type: EXPERIMENTAL

ISOFLURANE- Experimental Arm

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

James S McDonnell Foundation

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

George Mashour

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George A Mashour, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Michael Avidan, MBBCh

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Max Kelz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Mathias Basner, MD, PhD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Michigan

Ann Arbor, Michigan, United States

Washington University in St. Louis

St Louis, Missouri, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 33970101 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35183346 (View on PubMed)

Other Identifiers

McDonnell RCC

Identifier Type: -

Identifier Source: org_study_id