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