Improving Information Extraction From EEG on Cerebral Anesthetic Drug Effects

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-16

Study Completion Date

2015-06-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sedline EEG Guided Depth of Anesthesia

NCT05051982

Anesthesia Surgery

COMPLETED NA

Brain Function Monitoring During Surgery

NCT06619730

Surgery

RECRUITING NA

The Alternative Position for the SedLine® Sensor

NCT03947060

Depth of Anesthesia Monitoring

COMPLETED

The Neural Mechanisms of Anesthesia and Human Consciousness (Part 6)

NCT02624401

Anesthesia Unconsciousness

COMPLETED PHASE4

Comparison of Modulations of Motor Brain Activity and SedLine After Median Nerve Stimulation in General Anesthesia

NCT07267403

Accidental Awareness During General Anesthesia

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy Volunteers

All healthy volunteers will receive four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR).

Group Type EXPERIMENTAL

SedLine EEG sensor

Intervention Type DEVICE

Test subjects in each group will receive the same device intervention (SedLine EEG) to monitor their EEG waves.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SedLine EEG sensor

Test subjects in each group will receive the same device intervention (SedLine EEG) to monitor their EEG waves.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes