Propofol Pharmacokinetics and Pharmacodynamics Modelling

Intravenous Anesthetic Agent Overdose Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02713698
• Other study ID #: 2015.221(183-DEFI/165-CES)
• Status: Completed
• Start date: April 1, 2016
• Est. completion date: April 28, 2017

Study information

• Verified date: September 2018
• Source: Centro Hospitalar do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 28, 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients admitted for nose or ear surgery, bariatric surgery or urgent orthopaedic surgery.

Exclusion Criteria:

• Severe hepatic or renal insufficiency;

• Significant haemodynamic instability previous to the surgery;

• Allergy to eggs or propofol at the time of enrolment;

• Predictive criteria for difficult airway management.

Related Conditions & MeSH terms

• Intravenous Anesthetic Agent Overdose

Intervention

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.

Locations

Country	Name	City	State
Portugal	Centro Hospitalar do Porto	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Centro Hospitalar do Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Propofol Concentration (mcg/mL)	Arterial blood samples were obtained after LOC and every 20-30 minutes during propofol infusion. After stopping propofol infusion, arterial blood samples were obtained immediately after recovery of consciousness.; At the end of the surgery arterial blood samples were centrifuged at 2862xg for 5 minutes and they were preserved at -80ºC until analysis.; The quantification of propofol in serum was performed using gas chromatography/ion trap-mass spectrometry (GC/IT-MS)	up to 2 hours