UNderstanding CONSciousness Connectedness and Intraoperative Unresponsiveness Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-10

Study Completion Date

2020-03-12

Brief Summary

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This study will be a single-site, controlled, unblinded study at the University of Wisconsin to examine changes in the electroencephalogram during anesthesia and waking.

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Detailed Description

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\* 20 subjects will be recruited per drug, and subjects can be recruited to undergo multiple sedation protocols.

Screening:

Subjects will respond to the volunteer posts for the study by calling into a study specific phone number. They will complete a phone screening to determine basic eligibility for the study. At the beginning of the sedation session, participants will affirm that in the interval since their baseline visit, they have not acquired any of the cited exclusion criteria that would preclude participation. A review of these exclusion criteria will be completed by the Anesthesiologist. A standard pre-anesthetic assessment will be performed, including confirmation of NPO status, and documented using the standard Department of Anesthesiology pre-operative evaluation form.

The first sedative will be dexmedetomidine followed by ketamine, propofol and then midazolam (dependent on the availability of the drugs). Total enrollment in the study will be up to 80 subjects. Each sedation experiment will occur on separate days at least 28 days apart, if the subject chooses to participate in more than one session.

Conditions

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Unconsciousness Consciousness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Drug Administrated

Sedatives will be administered to participants while their brain activity is measured.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

20 participants will be administered Dexmedetomidine.

Ketamine

Intervention Type DRUG

20 participants will be administered Ketamine.

Propofol

Intervention Type DRUG

20 participants will be administered Propofol.

Midazolam

Intervention Type DRUG

20 participants will be administered Midazolam.

Interventions

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Dexmedetomidine

20 participants will be administered Dexmedetomidine.

Intervention Type DRUG

Ketamine

20 participants will be administered Ketamine.

Intervention Type DRUG

Propofol

20 participants will be administered Propofol.

Intervention Type DRUG

Midazolam

20 participants will be administered Midazolam.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18-40
* In good health, determined by the PI on the basis of medical history and a standard assessment for anesthesia to be documented as part of the study record
* Right handed, to standardize for asymmetry in brain functions

Exclusion Criteria

* Adults \<18 years old or \>40 years old
* Pregnancy confirmed on pregnancy test on day of sedation
* Contraindication to anesthesia or allergy to study drug
* Difficult anesthesia: American Society of Anesthesiologists Physical Status greater than 1, per the discretion of the PI. Examples of ASA status include, but are not limited to:

* Any systemic disease present, such as diabetes, cardiac, pulmonary, or other acute or chronic disorder, or history of smoking
* Narrow angle glaucoma
* Abnormal airway examination
* Any abnormality on medical history and physical examination
* Snoring or sleep disorders including apnea
* Antecedent pulmonary aspiration risk (e.g., history GI reflux, heartburn, hiatal hernia)
* Adverse reaction or allergy with anesthesia or other sedatives
* Chronic medication use
* History of difficult anesthesia, laryngoscopy or intubation
* Family history of difficulty with anesthesia or sedation
* History of vertigo, nausea or vomiting after anesthesia
* BMI \> 35
* Exclusion from Dexmedetomidine:

o Resting heart Rate\<60 bpm
* Exclusion from Propofol:

o Reported egg allergy
* Exclusion from Ketamine:

* History of post-operative nausea and vomiting
* History of motion sickness

* Anything to eat or drink for the preceding 8 hours
* Any use of over-the-counter or recreational drugs (including alcohol or tobacco) within the preceding 24 hours
* Any use of sedative or sleep agents within the preceding 24 hours
* Recent change in health, including cough, cold, or fever
* Exposure to anesthesia or sedation in the last 6 days

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes