NCT02713698

Propofol Pharmacokinetics and Pharmacodynamics Modelling

Modelling Propofol Pharmacokinetics and Pharmacodynamics During an Intravenous Anaesthesia Guided by the Bispectral Index (BIS)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Centro Hospitalar do Porto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this research is to develop a population pharmacokinetic and pharmacodynamic model of Propofol when used for induction and maintenance of anaesthesia, using BIS as a pharmacodynamic endpoint. A covariate analysis will be performed in order to account for variability in pharmacokinetic and pharmacodynamic parameters. The influence of age and obesity on propofol pharmacokinetic parameters will be particularly addressed.

Conditions

• Intravenous Anesthetic Agent Overdose

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-04-01
• Completion: 2017-04-28
• First posted: 2016-03-21
• Last updated: 2018-09-26
• Results posted: 2018-09-26

Locations

1 site across 1 country: Portugal