Status:
COMPLETED
UNderstanding CONSciousness Connectedness and Intraoperative Unresponsiveness Study
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Unconsciousness
Consciousness
Eligibility:
All Genders
18-40 years
Phase:
PHASE4
Brief Summary
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.
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2020
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03284307
Start Date
August 10 2017
End Date
March 12 2020
Last Update
April 13 2023
Active Locations (1)
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1
UW Hospital and Clinics
Madison, Wisconsin, United States, 53792