N/A
N=46
Improving Information Extraction From EEG on Cerebral Anesthetic Drug Effects
Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT02043938 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Patient State Index (PSI) Comparison, Baseline and Emax — 85.1; 63.1; 63.1; 67.2 index
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SedLine EEG sensor (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Masimo Corporation
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient State Index (PSI) Comparison, Baseline and Emax |
85.1; 63.1; 63.1; 67.2; 67.2; 85.1 | — |
Summary
This is an interventional, randomized controlled study in health volunteers that involves collecting data on raw EEG waves measuring various combinations of anesthetic drugs during standardized drug titration.
Eligibility Criteria
Inclusion Criteria
- Healthy volunteers aged 18 to 70 years
- Concerning the cognitive function: Volunteers are considered to have sufficient cognitive reserve if they are able to read and comprehend the patient information form, if they can adequately answer the anamnestic questions during the screening process and if they are allowed to provide legitimate written informed consent
- No selection will be made regarding ethnic background.
- For this study no control group has been selected as EEG is compared between episodes rather than between individuals (each volunteer is his/her own control)
Exclusion Criteria
Volunteer refusal
- Volunteer 70 years
- Pregnancy
- Exclusion criteria are weight less than 70% or more than 130% of ideal body weight
- Neurological disorder (epilepsy, the presence of a brain tumor, a history of brain surgery, hydrocephalic disorders, depression needing treatment with anti-depressive drugs, a history of brain trauma, a subarachnoidal bleeding, TIA or cerebral infarct, psychosis or dementia , schizophrenia, alcohol or drug abuse).
- Diseases involving the cardiovascular system (hypertension, coronary artery disease, prior acute myocardial infarction, any valvular and/or myocardial disease involving decrease in ejection fraction, arrhythmias, which are either symptomatic or require continuous medication/pacemaker/automatic internal cardioverter defibrillator
- Pulmonary Diseases
- Gastric Diseases
- Endocrinologic diseases
- Recent use of psycho-active medication (benzodiazepines, anti-epileptic drugs, parkinson medication, anti-depressant drugs, opioids) or more than 20g of alcohol daily
Data sourced from ClinicalTrials.gov (NCT02043938). 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.