Overview

UNderstanding CONSciousness Connectedness and Intraoperative Unresponsiveness Study

Status:
Active, not recruiting
Trial end date:
2022-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Wisconsin, Madison
Treatments:
Dexmedetomidine
Ketamine
Midazolam
Propofol
Sevoflurane
Criteria
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