- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03284307
UNderstanding CONSciousness Connectedness and Intraoperative Unresponsiveness Study (UN-CONSCIOUS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
* 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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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Wisconsin
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Madison, Wisconsin, United States, 53792
- UW Hospital and Clinics
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
- Contraindication to HD-EEG, TMS or MRI for relative parts of the procedures. MRI exclusion criteria: presence of metallic or electronic implants; history of claustrophobia. TMS exclusion criteria: Presence or history of medical conditions that could increase the chance of seizures (e.g. - stroke, aneurysm, brain surgery, structural brain lesion) cranial metal implants; structural brain lesion; devices that may be affected by TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator); history of head trauma with loss of consciousness for greater than 5 minutes; family history of seizures; history of antecedent mood disorder.
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
Additional exclusion criteria on the day of sedation:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Drug Administrated
Sedatives will be administered to participants while their brain activity is measured.
|
20 participants will be administered Dexmedetomidine.
20 participants will be administered Ketamine.
20 participants will be administered Propofol.
20 participants will be administered Midazolam.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occipital Delta Power Spectral Density by Conscious State and Study Group.
Time Frame: Intraoperative (During sedation-- up to 8 hours)
|
The difference in spontaneous EEG slow wave activity over posterior cortex between states of consciousness measured with high-density EEG equipment and reported in spectral power in the delta band (1-4 Hz) at electrode Oz.
Disconnected conscious experience (dreaming), connected conscious experience (awareness of the external world), and unconsciousness (no report) was assessed when participants were roused from sedation or sleep.
|
Intraoperative (During sedation-- up to 8 hours)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of Study Drug on Ability to Correctly Identify Shapes/Images
Time Frame: Intraoperative (During sedation-- up to 8 hours)
|
The ability to identify shapes/images in visual illusions measured by the NIH Toolbox.
Will be reported by a computed score from NIH Toolbox for the Dimensional Change Card Sort Test (DCCS) and the Flanker Inhibitory Control & Attention Test (Flanker).
Both Flanker and DCCS use a 2-vector scoring method that takes accuracy and reaction time (if accuracy >=80%) into account, resulting in a computed score that can range in value from 0-10.
A higher score indicates better performance on the test.
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Intraoperative (During sedation-- up to 8 hours)
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Effect of Study Drug on Ability to Form Implicit Memory
Time Frame: Intraoperative (During sedation-- up to 8 hours)
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Subjects will have a list of words read to them while under sedation and their ability to hear these words and form implicit memories of them will be assessed using a two-alternative forced choice task.
Results will be reported as the average number of correct responses out of sixteen.
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Intraoperative (During sedation-- up to 8 hours)
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Number of Instances of Disconnected Conscious Experience (Dreaming) vs Connected Conscious Experience (Awareness of External World).
Time Frame: Intraoperative (During sedation-- up to 8 hours)
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The number of instances of disconnected conscious experience (dreaming) versus connected conscious experience (awareness of the external world) during sedation is measured by subject self-report at the time of researcher initiated inquiry.
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Intraoperative (During sedation-- up to 8 hours)
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Effect of Study Drug on Ability to Correctly Identify Images
Time Frame: Intraoperative (During sedation-- up to 8 hours)
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The ability to match sounds and images measured by the predictive coding task.
Will be reported by a proportion correct as a decimal.
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Intraoperative (During sedation-- up to 8 hours)
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Consciousness Disorders
- Unconsciousness
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Ketamine
- Midazolam
- Propofol
- Dexmedetomidine
Other Study ID Numbers
- 2015-1399
- A530900 (Other Identifier: UW Madison)
- SMPH\ANESTHESIOLOGY\ANESTHESIO (Other Identifier: UW Madison)
- Protocol Version 10/18/2019 (Other Identifier: UW Madison)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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