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.

Conditions: This study is performed in healthy volunteers. The study is aimed at investigating the effect of propofol and remifentanil-propofol interaction on breathing in awake, non-artificially ventilated volunteers under non steady state conditions.

Registration Number: EUCTR2010-018233-21-NL

Lead Sponsor: eiden University Medical Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Healthy volunteers of either sex in age range 18-45 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Study aims:<br>- to assess the dose-response relationship of propofol on breathing<br>- to the interaction of propofol and remifentanil on breathing.<br>;Secondary Objective: - to quantify the data under closed-loop conditions using an empirical model of the drug-induced respiratory depression that incorporates drug effect on respiratory neurons and the kinetics and dynamics of CO2.;Primary end point(s): Primary study parameter is the breathing/ventilation compared to baseline after start of the infusion. Ventilation will be monitored by continuous measurement of the spontaneous ventilation (ltr/min) by breathing through a mask that is connected to a pneumotachograph. Furthermore, breathing will be assessed by end tidal O2 and CO2 concentrations, continuously measured by a capnograph. Also, arterial saturation will be monitored by pulse-oximetry.<br>Bloodsampling will be carried out frequently (15 times in total), in order to obtain information about drug concentrations in the blood. <br>

Secondary Outcome Measures