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.
Conditions
Interventions
Product Name: Propofol
Product Code: Propofol
Pharmaceutical Form: Intravenous infusion
Product Name: Remifentanil
Product Code: Remifentanil
Pharmaceutical Form: Intravenous infusion
Sponsors
Leiden University Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Study aims: - to assess the dose-response relationship of propofol on breathing - to the interaction of propofol and remifentanil on breathing. ;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. Bloodsampling will be carried out frequently (15 times in total), in order to obtain information about drug concentrations in the blood. | — |
Countries
Netherlands
Outcome results
None listed