Clinical trial NCT02043938: Improving Information Extraction From EEG on Cerebral Anesthetic Drug Effects
Official title: 'Study of the Cerebral Effects of Sevoflurane, Propofol and Remifentanil as Measured by the Spontaneous Electro-encephalogram'
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: Electroencephalography
pharmacological
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
Collaborators: name: University Medical Center Groningen
First posted: 2014-01-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 \< 18 years and \>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

Primary outcomes:
measure: Patient State Index (PSI) Comparison, Baseline and Emax
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
measure: Patient State Index (PSI) Comparison, C50 (Sevoflurane, Sevoflurane+Remifentanil)
timeFrame: 6 weeks
measure: Patient State Index (PSI) Comparison, C50 (Propofol, Propofol+Remifentanil)
timeFrame: 6 weeks
measure: Propofol, Sevoflurane, and Remifentanil Interaction.
timeFrame: 6 weeks
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
citation: Su H, Eleveld DJ, Struys MMRF, Colin PJ. Mechanism-based pharmacodynamic model for propofol haemodynamic effects in healthy volunteers☆. Br J Anaesth. 2022 May;128(5):806-816. doi: 10.1016/j.bja.2022.01.022. Epub 2022 Mar 3.
citation: Ramaswamy SM, Kuizenga MH, Weerink MAS, Vereecke HEM, Struys MMRF, Belur Nagaraj S. Frontal electroencephalogram based drug, sex, and age independent sedation level prediction using non-linear machine learning algorithms. J Clin Monit Comput. 2022 Feb;36(1):121-130. doi: 10.1007/s10877-020-00627-3. Epub 2020 Dec 14.
citation: Ramaswamy SM, Kuizenga MH, Weerink MAS, Vereecke HEM, Struys MMRF, Nagaraj SB. Novel drug-independent sedation level estimation based on machine learning of quantitative frontal electroencephalogram features in healthy volunteers. Br J Anaesth. 2019 Oct;123(4):479-487. doi: 10.1016/j.bja.2019.06.004. Epub 2019 Jul 18.
citation: Kuizenga MH, Colin PJ, Reyntjens KMEM, Touw DJ, Nalbat H, Knotnerus FH, Vereecke HEM, Struys MMRF. Test of neural inertia in humans during general anaesthesia. Br J Anaesth. 2018 Mar;120(3):525-536. doi: 10.1016/j.bja.2017.11.072. Epub 2017 Dec 1.