Propofol Pharmacokinetics and Pharmacodynamics Modelling

September 22, 2018 updated by: Ana M Araujo, Centro Hospitalar do Porto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Porto, Portugal, 4099-001
        • Centro Hospitalar do Porto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Inpatient care at Centro Hospitalar do Porto

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1 (≥18 years, BMI<35kg/m2)
Patients with 18 or more years presenting for inpatient nose and ear surgery.
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.
Group 2 (≥18 years, ≥35kg/m2)
Patients with 18 or more years presenting for inpatient bariatric surgery.
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.
Group 3 (≥65 years)
Patients with 65 or more years presenting for orthopaedic surgery.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Hospitalar do Porto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2016

Primary Completion (ACTUAL)

April 1, 2017

Study Completion (ACTUAL)

April 28, 2017

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

March 15, 2016

First Posted (ESTIMATE)

March 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 26, 2018

Last Update Submitted That Met QC Criteria

September 22, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015.221(183-DEFI/165-CES)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intravenous Anesthetic Agent Overdose

Clinical Trials on Propofol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe