Propofol Pharmacokinetics and Pharmacodynamics Modelling

Centro Hospitalar do Porto

Status: Completed

Conditions: Intravenous Anesthetic Agent Overdose

Treatments: Drug: Propofol

Study type: Observational

Funder types: Other

Identifiers

NCT02713698

2015.221(183-DEFI/165-CES)

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 3 patient groups

Group 1 (≥18 years, BMI<35kg/m2)

Description:

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

Treatment:

Drug: Propofol

Group 2 (≥18 years, ≥35kg/m2)

Description:

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

Treatment:

Drug: Propofol

Group 3 (≥65 years)

Description:

Patients with 65 or more years presenting for orthopaedic surgery.

Treatment:

Drug: Propofol