At a glance
ClinicalIndex Comparison Record- ✓Age 18-60 years, healthy with ASA physical status 1
- ✓Vital signs within specified ranges: HR 45-90 bpm, SBP 110-140 mmHg, DBP 50-90 mmHg
- ✓Room air oxygen saturation ≥95% by pulse oximetry
- ✓Normal pulmonary function on spirometry
- ✕Known neurological disorders including epilepsy, brain tumor, brain surgery history, hydrocephalus, depression requiring treatment, or brain trauma
- ✕Known cardiovascular disease including hypertension, CAD, prior MI, valvular/myocardial disease, arrhythmias, or implanted pacemaker/AICD
- ✕Psychoactive medications within past 60 days (benzodiazepines, antiepileptic drugs, Parkinson's medications, antidepressants, opioids)
- ✕Known history of malignant hyperthermia
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of BIS™ and Levels of Sedation With Common Inhalational Anesthetics in Healthy Volunteers (OLIVER)
In Brief
A clinical study evaluating BIS Complete Monitoring System for Anesthesia. Completed, enrolled 211 participants across 3 sites.
Detailed Summary
To investigate the relationship between BIS™ and inhaled anesthetics across a wide range of anesthetic concentration and hypnotic states, and to provide evidence to support BIS™ performance in use with Isoflurane, Sevoflurane and Desflurane in combination with opioids.
Study Details
Timeline
Interventions
The BIS™ EEG complete monitoring system is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The system and its associated parameters are intended for use on adult patients within a hospital or medical facility, providing patient care to monitor the state of the brain by data acquisition of EEG signals.