Intravenous Anesthetic Agent OverdoseNCT02713698
Propofol Pharmacokinetics and Pharmacodynamics Modelling
An observational study of Intravenous Anesthetic Agent Overdose, run by Centro Hospitalar do Porto at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intravenous Anesthetic Agent Overdose
- What is being tested?
- Propofol
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Apr 2016to 28 Apr 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatient care at Centro Hospitalar do Porto
Who may be able to join
- Adult patients admitted for nose or ear surgery, bariatric surgery or urgent orthopaedic surgery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Intravenous Anesthetic Agent Overdose
- Being tested
- Propofol
- Keywords
- Anaesthetics, Intravenous, Propofol, Pharmacokinetics, Pharmacodynamics, Propofol pharmacokinetic-pharmacodynamic model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (≥18 years, BMI<35kg/m2) | Patients with 18 or more years presenting for inpatient nose and ear surgery. Receives: Drug: Propofol | |
| Group 2 (≥18 years, ≥35kg/m2) | Patients with 18 or more years presenting for inpatient bariatric surgery. Receives: Drug: Propofol | |
| Group 3 (≥65 years) | Patients with 65 or more years presenting for orthopaedic surgery. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study start1 Apr 2016
- Primary completionApr 2017
- Study completion28 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intravenous Anesthetic Agent OverdoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana M Araujo, Centro Hospitalar do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713698
- Sponsor's protocol ID
- 2015.221(183-DEFI/165-CES)
- Status last verified
- Sep 2018
- First submitted
- 23 Feb 2016
- Last updated
- 26 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Araujo AM, Machado HS, Falcao AC, Soares-da-Silva P. Bioelectrical impedance analysis of body composition for the anesthetic induction dose of propofol in older patients. BMC Anesthesiol. 2019 Oct 11;19(1):180. doi: 10.1186/s12871-019-0856-x.
PubMed 31604419
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modelling Propofol Pharmacokinetics and Pharmacodynamics During an Intravenous Anaesthesia Guided by the Bispectral Index (BIS)
- ClinicalTrials.gov ID
- NCT02713698
- Acronym / sponsor ID
- 2015.221(183-DEFI/165-CES)
- Conditions
- Intravenous Anesthetic Agent Overdose
- Keywords
- Anaesthetics, Intravenous, Propofol, Pharmacokinetics, Pharmacodynamics, Propofol pharmacokinetic-pharmacodynamic model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centro Hospitalar do PortoUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Posted 26 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (≥18 years, BMI<35kg/m2) | – | Drug: PropofolPatients with 18 or more years presenting for inpatient nose and ear surgery. |
| Group 2 (≥18 years, ≥35kg/m2) | – | Drug: PropofolPatients with 18 or more years presenting for inpatient bariatric surgery. |
| Group 3 (≥65 years) | – | Drug: PropofolPatients with 65 or more years presenting for orthopaedic surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatient care at Centro Hospitalar do Porto
Key inclusion criteria (1 listed)
- Adult patients admitted for nose or ear surgery, bariatric surgery or urgent orthopaedic surgery.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolThe 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. | Drug | Group 1 (≥18 years, BMI<35kg/m2), Group 2 (≥18 years, ≥35kg/m2), Group 3 (≥65 years) |
Primary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31604419Araujo AM, Machado HS, Falcao AC, Soares-da-Silva P. Bioelectrical impedance analysis of body composition for the anesthetic induction dose of propofol in older patients. BMC Anesthesiol. 2019 Oct 11;19(1):180. doi: 10.1186/s12871-019-0856-x.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intravenous Anesthetic Agent Overdose, run by Centro Hospitalar do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Propofol Concentration (mcg/mL) (time frame: up to 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02713698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.