Modeling the respiratory effects of subanesthetic doses of propofol under closed-loop or non-steady-state conditions without and with a remifentanil background infusion in healthy volunteers.

Completed

Conditions: Ventilatie/ademhaling
Respiratory effects of propofol and remifentanil

Registration Number: NL-OMON34762

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

Healthy volunteers of either sex in age range 18-45 years.

Exclusion Criteria

Obesity (BMI > 35)
Presence of medical disease
Presence of psychiatric disease
History of chronic alcohol or illicit drug use
Allergy to study medications
Difficult to hold to subject on mask causing leakage and inability to perform mask ventilation (i.e. Mallampati classification 3 or greater)
For females we require use of contraceptives

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study parameter is the breathing/ventilation compared to baseline after<br /><br>start of the infusion. Ventilation will be monitored by continuous measurement<br /><br>of the spontaneous ventilation (ltr/min) by breathing through a mask that is<br /><br>connected to a pneumotachograph. Furthermore, breathing will be assessed by end<br /><br>tidal O2 and CO2 concentrations, continuously measured by a capnograph. Also,<br /><br>arterial saturation will be monitored by pulse-oximetry.<br /><br>Bloodsampling will be carried out frequently (15 times in total), in order to<br /><br>obtain information about drug concentrations in the blood.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The following measurements will be performed during the experiment;<br /><br>ECG and heart rate - continous measurement during the 6 h study.<br /><br>Bloodpressure - continuous measurement from the arterial line continously<br /><br>during the study.<br /><br>EEG - for signs of sedations - continously during the study.</p><br>