UNderstanding CONSciousness Connectedness and Intraoperative Unresponsiveness Study

Completed · Phase 4

Conditions studied: Unconsciousness, Consciousness

In brief

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.

Key facts

Study ID

NCT03284307

Run by

University of Wisconsin, Madison

People needed

35

Starts

2017-08-10

Expected to finish

2020-03-12

Last updated by the study team

2023-04-13

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:

Where it is running

• UW Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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