Study of the cerebral effects of sevoflurane, propofol and remifentanil as measured by the spontaneous electro-encephalogram

Completed

Conditions: gezonde vrijwilligers die onder anesthesie worden gebracht
Anesthesia administration
Anesthesia monitoring
10009720

Registration Number: NL-OMON40298

Lead Sponsor: MASIMO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 36

Inclusion Criteria

Healthy volunteers aged 18 to 70 years.
18-35 y 6 men / 6 women
35-50 y 6 men / 6 women
50-70 y 6 men / 6 women

Exclusion Criteria

Volunteer refusal
- Volunteer < 18 years and >70 years
- Exclusion criteria are weight less than 70% or more than 130% of ideal body weight
- Neurological disorder
- 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 or more than 20 g of alcohol daily.
-Drug abuse

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The predicted population plasma and effect-site concentration of propofol and<br /><br>remifentanil at every steady state step during induction and recovery and<br /><br>during bolus dose administration.<br /><br>The measured individual plasmaconcentration of propofol and remifentanil at<br /><br>every steady state step during induction and recovery and during bolus dose<br /><br>administration.<br /><br>The total dose administered over time for all drugs involved<br /><br>The end-tidal sevoflurane concentration for every steady state step during<br /><br>inductie and recovery and during the bolus administration<br /><br>The multichannel raw EEG signals during the total study duration<br /><br>The observers assesment of alertness and sedation scale at every steady state<br /><br>step during the induction and during recovery fase.<br /><br>The presence or abcense of a somatic response after a standardized tetanic<br /><br>stimulation during every steady state step during induction and recovery. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The heart frequency, oxygen saturation (plethysmogram), non invasive<br /><br>bloodpressure measurement and end-tidal CO2 monitoring, as well as the signal<br /><br>of the Rainbow Acoustic Monitor (Masimo, Irvine, CA, USA) will be stored to<br /><br>ensure and document the safety of the volunteers throughout the study.<br /><br>Moreover, hemodynamic effects may also be set in relation to drug concentration<br /><br>changes in order to observe the timecourse differences between desired EEG<br /><br>effects and </p><br>