Real time monitoring of blood propofol concentration

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000537-69-BE

Enrollment

Registered

2015-08-24

Start date

2015-09-21

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Trade Name: Diprivan Product Name: propofol Pharmaceutical Form: Emulsion for injection/infusion INN or Proposed INN: Propofol CAS Number: 82597-74-8 Other descriptive name: PROPOFOL Concentration uni

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - >18-70 years - ASA I, II - Weight not exceeding 50 % under or above normal ideal body weight Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: - Pregnancy - ASA III and ASA IV

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to evaluate the pharmacokinetic and pharmacodynamics profile of 2 different solutions of propofol 2 % : propofol 2 % by AstraZeneca with EDTA(ethylene diamine tetraacetic acid, United Kingdom) on one hand and propofol 2 % by Fresenius Kabi without EDTA(Germany) on the other hand.;Secondary Objective: We will also investigate if there is a difference in inflammatory parameters (white cell blood count and C-reactive protein) between the two above groups. Thirdly we will study influence of changes in cardiac output on the pharmacokinetics of propofol. As for drugs such as propofol, that undergo extensive hepatic extraction, clearance will be proportional to the hepatic flow and cardiac output, which can easily change during surgery in response to surgical stimulation or administration of inotropic drugs. This means that we can suppose that the actual blood concentrations of propofol might substantially deviate from the expected concentrations in a low or a high cardiac output state.;Primary end point(s): Real plasma concentration of Propofol compared to the predicted propofol concentration by the pharmacokinetic model.;Timepoint(s) of evaluation of this end point: - At loss of conscious - 1,5,7,10,15 and 30 minutes after induction and every 30 minutes untill 2 hours after the procedure. - 5 minutes after every change in target propofol concentration.	—

Measure

Time frame

Main Objective: The primary objective of this study is to evaluate the pharmacokinetic and pharmacodynamics profile of 2 different solutions of propofol 2 % : propofol 2 % by AstraZeneca with EDTA(ethylene diamine tetraacetic acid, United Kingdom) on one hand and propofol 2 % by Fresenius Kabi without EDTA(Germany) on the other hand.;Secondary Objective: We will also investigate if there is a difference in inflammatory parameters (white cell blood count and C-reactive protein) between the two above groups. Thirdly we will study influence of changes in cardiac output on the pharmacokinetics of propofol. As for drugs such as propofol, that undergo extensive hepatic extraction, clearance will be proportional to the hepatic flow and cardiac output, which can easily change during surgery in response to surgical stimulation or administration of inotropic drugs. This means that we can suppose that the actual blood concentrations of propofol might substantially deviate from the expected concentrations in a low or a high cardiac output state.;Primary end point(s): Real plasma concentration of Propofol compared to the predicted propofol concentration by the pharmacokinetic model.;Timepoint(s) of evaluation of this end point: - At loss of conscious - 1,5,7,10,15 and 30 minutes after induction and every 30 minutes untill 2 hours after the procedure. - 5 minutes after every change in target propofol concentration.

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Secondary

Measure	Time frame
Secondary end point(s): investigate if there is a difference in inflammatory parameters Cardiac output;Timepoint(s) of evaluation of this end point: - 24 hrs postoperatively	—

Countries

Belgium

Contacts

Public ContactDatanurse

Veerle Van Mossevelde

veerle.vanmossevelde@uzbrussel.be3224763134

Outcome results