Phase 4
N=29
Neuroimaging of Anesthetic Modulation of Human Consciousness
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03361605 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Change From Baseline in Blood Oxygen Level Dependent (BOLD) Response to Sensory Stimuli During Sedation — -0.349 percentage of BOLD signal change — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Propofol (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Blood Oxygen Level Dependent (BOLD) Response to Sensory Stimuli During Sedation |
-0.349 | <0.0001 sig |
| SECONDARY Change From Baseline in Squeeze Pressure |
-2.16 | 0.00148 sig |
Summary
This study's purpose is to see if mental functions take place during different levels of anesthesia, using a commonly used drug (Propofol). fMRI (functional Magnetic Resonance Imaging, or "brain imaging") shows areas in the brain involved in thinking at different depths of anesthesia.
Eligibility Criteria
Inclusion Criteria
- Must have a body mass index (BMI) less than 30.
- Must be right handed
- Must be English speaking
- Must be capable of giving written informed consent.
- Must have history of playing tennis (or any type of racquet sport) at least 30 times over lifetime.
Exclusion Criteria
- History of obstructive sleep apnea;
- History of a difficult airway with a previous anesthetic;
- History of neurological disorders;
- Hypertension or other cardiovascular abnormalities;
- Pulmonary hypertension or other pulmonary abnormalities;
- Gastroesophageal reflux disease (GERD) or heartburn;
- History of significant head injury with loss of consciousness;
- Learning disability or other developmental disorder;
- Allergic reactions to eggs;
- Pregnant or nursing mothers;
- Contraindications to neuroimaging methods;
- Inability or unwilling to fast, or withhold food and liquid intake, for 8 hours prior to your scheduled study visit.
- Unwilling to abstain from alcohol use for 24 hours prior to your scheduled study visit.
- History of drug use, or have a positive drug screen.
- Tattoos on the head or neck region - all other tattoos are subject to determination by investigators.
- Any impairment, activity or situation that in the judgment of the study coordinator or Principal Investigators would prevent satisfactory completion of the study protocol.
Data sourced from ClinicalTrials.gov (NCT03361605). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.