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NCT Number: NCT02713698

Propofol Pharmacokinetics and Pharmacodynamics Modelling

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.

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Key information

Conditions

Intravenous Anesthetic Agent Overdose

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Hospitalar do Porto

Porto, 4099-001, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propofol

Drug

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.

Primary outcomes

  1. Plasma Propofol Concentration (mcg/mL)

    Time frame: up to 2 hours

    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)

Sponsors and collaborators

Lead sponsor

Centro Hospitalar do Porto

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 21, 2016
Registry last updated
Sep 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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