Propofol Pharmacokinetics and Pharmacodynamics Modelling

NCT02713698 | Completed Results

• 1 other identifier: 2015.221(183-DEFI/165-CES)
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Anaesthetics; Intravenous; Propofol; Pharmacokinetics; Pharmacodynamics; Propofol pharmacokinetic-pharmacodynamic model

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Group 1 (≥18 years, BMI<35kg/m2)

Patients with 18 or more years presenting for inpatient nose and ear surgery.

Drug: Propofol

Group 2 (≥18 years, ≥35kg/m2)

Patients with 18 or more years presenting for inpatient bariatric surgery.

Drug: Propofol

Group 3 (≥65 years)

Patients with 65 or more years presenting for orthopaedic surgery.

Drug: Propofol

Interventions

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.

Group 1 (≥18 years, BMI<35kg/m2); Group 2 (≥18 years, ≥35kg/m2); Group 3 (≥65 years)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatient care at Centro Hospitalar do Porto

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Hospitalar do Porto: lead

Study Sites (1)

Centro Hospitalar do Porto

Porto, 4099-001, Portugal

Location

Related Publications (1)

• 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.

  PMID: 31604419 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Arterial blood samples will be collected in serum tubes and centrifuged at 2000 rpm for 15 minutes in order to obtain serum. Serum will be preserved at -80ºC until analysis.

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Ana Maria Araujo
• Organization: Centro Hospitalar do Porto

amfariaaraujo@gmail.com

22 2077549

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 21, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 28, 2017
• Last Updated: September 26, 2018
• Results First Posted: September 26, 2018

Record last verified: 2018-09

Locations

PT (1)