Ademhalingsstudie naar de interactie tussen remifentanil en propofol in gezonde vrijwilligers.

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.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON19898

Enrollment

Registered

2010-12-03

Start date

2010-11-18

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breathing BIS Healthy volunteers Remifentanil Propofol Ademhaling Gezonde vrijwilligers PK-PD

Interventions

24 volunteers will participate in two experimental runs lasting about 1 hr with a 2 hr washout period in between. During each experimental run a 30 minutes infusion of propofol (first run) or propofo

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy volunteers of either sex; 2. Age 18-45 years.

Exclusion criteria

Exclusion criteria: 1. BMI > 35; 2. Presence of any medical disease; 3. History of drug or alcohol abuse; 4. Allergy to study medications; 5. Mallampati 3 or greater; 6. For females: Use of contraceptives required.

Design outcomes

Primary

Measure	Time frame
1. Ventilation (l/min); 2. EEG monitoring via BIS; 3. Bloodsampling for propofol concentrations.	—

Secondary

Measure	Time frame
1. Cardiac output; 2. Heartrate; 3. Saturation.	—

Contacts

Public ContactAlbert Dahan

Leiden University Medical Center (LUMC), Department of Anesthesiology, P.O. Box 9600

a.dahan@lumc.nl+31 (0)71 5262301

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)