Propofol Pharmacokinetics and Pharmacodynamics Modelling

CompletedOBSERVATIONAL
Enrollment

60

Participants

Timeline

Start Date

April 1, 2016

Primary Completion Date

April 30, 2017

Study Completion Date

April 28, 2017

Conditions
Intravenous Anesthetic Agent Overdose
Interventions
DRUG

Propofol

"The whole anaesthetic procedure is standard except for additional body composition assessment with Body Composition Monitor - BCM (Fresenius Medical Care, Germany) and arterial blood samples collection.~In all included patients, propofol will be started at 2000mg/h until LOC, defined by loss of eye-lash reflex and loss of response to name calling. During surgery propofol infusion will be guided by targeted BIS values between 40 and 60.~Arterial blood samples will be obtained immediately after LOC and after every 20-30 minutes during propofol infusion. After stopping propofol infusion, arterial blood samples will be acquired every 10 minutes until recovery of consciousness. The maximum blood sample per patient will be 20 mL."

Trial Locations (1)

4099-001

Centro Hospitalar do Porto, Porto

All Listed Sponsors
lead

Centro Hospitalar do Porto

OTHER

NCT02713698 - Propofol Pharmacokinetics and Pharmacodynamics Modelling | Biotech Hunter | Biotech Hunter