Propofol Pharmacokinetics and Pharmacodynamics Modelling

Completed

• Conditions: Intravenous Anesthetic Agent Overdose
• Interventions: Drug: Propofol

• Registration Number: NCT02713698
• Lead Sponsor: Centro Hospitalar do Porto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-23
• Study First Submitted QC: 2016-03-15
• Study First Posted: 2016-03-21
• Study Start: 2016-04-01
• Primary Completion: 2017-04
• Study Completion: 2017-04-28
• Results First Submitted: 2018-01-24
• Status Verified: 2018-09
• Results First Submitted QC: 2018-09-22
• Last Update Submitted: 2018-09-22
• Results First Posted: 2018-09-26
• Last Update Posted: 2018-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Plasma Propofol Concentration (mcg/mL)	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)

Trial Locations

Locations (1)

Centro Hospitalar do Porto; 🇵🇹 Porto, Portugal