|- candidate number||14894|
|- NTR Number||NTR3995|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-mei-2013|
|- Secondary IDs||2013/083 MEC UZ Brussel|
|- Public Title||REAL-TIME BEDSIDE MONITORING OF BLOOD PROPOFOL CONCENTRATIONS: |
|- Scientific Title||REAL-TIME BEDSIDE MONITORING OF BLOOD PROPOFOL CONCENTRATIONS: |
Comparison between propofol 2% and propofol 1%
|- hypothesis||1) The aim of this study will be to prospectively test the validity of this rapid propofol measurement system (Sphere Pelorus) during TIVA anaesthesia. |
2) Assesment of interference between propofol bloodconcentrations and sufentanil or remifentanil.
|- Healt Condition(s) or Problem(s) studied||Propofol, Ear surgery, Intrancranial neurosurgical intervention, Nociception, Opioids |
|- Inclusion criteria||Male and female non-pregnant patients scheduled for elective intracranial surgery or ear surgery with a minimal duration of at least 3 hours.|
ASA Physical status I or II
Age between 18-65 years
|- Exclusion criteria||Serious impairment of respiratory, cardiovascular, hepatic, renal, haematopoetic or endocrine function.
Known allergy to propofol or constituents (Soya-bean-eggs).|
Previous adverse experience of general anaesthesia.
More than 50% under or above ideal weight.
History of opioid drug abuse or alcohol addiction.
Concurrent use of beta-blockers
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-mei-2013|
|- planned closingdate||15-mei-2014|
|- Target number of participants||24|
|- Interventions||Part I: A comparison of blood propofol concentrations during a TCI administration of a 1% or 2% formulations of propofol during intracranial neurosurgical interventions:|
I.V. line for propofol and remifentanil infusion
Administration of propofol: set target Cp at 4 µg/ml blood concentration. (Alaris PK pump, PK model Marsh).After 3 min start TCI propofol.
Remifentanil target controlled infusion
Administration of remifentanil: set blood target Cp at desired concentration ( 0.2 ng/ml to start)
start TCI propofol
Intubation and ventilaiton
Hypnotic and analgesic effects during anaesthesia and surgery will be assessed by the haemodynamic and autonomic responses to surgical stimulation i.e.:
• An increase of systolic blood pressure > 20% from postinduction baseline value
• An increase of heart rate > 20% fom postinduction baseline value
Each sign of arousal will be treated with increased target concentration of remifentanil
Monitoring of vital signs (SBP, DBP, MAP, HR and SaO2) every minute from start TCI propofol
In order to study the influence of the position a Nexfin continuous non-invasive blood pressure and cardiac output monitor will be used.
Part II: Influence of opioid supplementation with sufentanil or remifentanil on the real time blood concentrations of propofol during TCI.
After preoxygenation with 100%oxygen for 3 min all patients will receive a bolus dose of 15 µg sufentanil, followed 3 min later by a target controlled infusion of propfol at 4 µg ml-1 (Alaris PK pump, Pharmacokinetic model of Marsh) .
After intubation a target controlled infusion of remifentanil at 2 ng/ml (Alaris PK pump, PK modelof Minto) or a target controlled infusion of sufentanil 0.3 ng/ml (Alaris PK pump, PK model of Gepts) will be started. If the patient present signs of inadequate anaesthesia (Increase with 20% of baseline blood pressure or heart rate) this opioid infusion may be increased with steps of 1 ng/ml remifentanil or 0.1 ng/ml sufentanil.
|- Primary outcome||Part I: The aim of this study will be to prospectively test the validity of these rapid propofol measurement system (Shpere Pelorus) during TIVA anaesthesia.
|- Secondary outcome||In a second time we will investigate:|
• the pharmacokinetic interaction between propofol and remifentanil
• influence of positioning during surgery ad ossible associated changes in CO (dorsal vs ventral decubitus) on pharmacokinetics of propofol
• influence of administration of manitol on plasma concentrations of propofol
• gender differences in pharmacokinetics and dynamics of propofol
• the influence of age on pharmacokinetics of propofol
• possible impact of pain medication (paracetamol) on pharmacokinetics of propofol
Part II:Influence of opioid supplementation with sufentanil or remifentanil on the real time blood concentrations of propofol during TCI.
Determine whether the blood propofol concentrations are influenced by concomitant administration of sufentanil or remifentanil
|- Timepoints||Arterial blood samples for propofol concentration determinations will be taken at the following timepoints:|
2) After start propofol every 15' during 1 hour
3) Every 30' until the endof the intervention
4) 5' after each change in TCI of propofol
5) Before and after administration of manitol
6) The moment of detubation
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Veerle Mossevelde, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Caroline Iersberghe,van|
|- Sponsor/Initiator ||Universitair Ziekenhuis Brussel|
(Source(s) of Monetary or Material Support)
|Universitair Ziekenhuis Brussel|
|- Brief summary||A method to determine blood concentrations of propofol is desirable to improve the safety and adjust anaesthetic depth. The ability to monitor the blood concentration of propofol in real time would allow us to better titrate and provide adequate anaesthesia throughout a surgical procedure.
While real time monitoring of inhaled anaesthetic concentration is a standard of care there is until now no equivalent commercially available system for the measurement of propofol. Current validated methods of analysis are laboratory based assays requiring considerable time for sample preparation and analysis. These are suitable for population pharmacokinetic studies, but the slow turnaround time of such tests preclude there application to real time management of patients. Estimations of blood propofol concentrationfrom expired gases has yet to demonstrate consistent and reliable results. |
Sphere Medical (Camebridge UK) has introduced the Pelorus 1000 propofol measurement system, which has been designed for rapid analysis of propofol concentration in whole blood samples. A sample of 0.7 ml is required and the whole blood propofol concentration is determined in approximately 5 min. The measurement technology used in the Pelorus is based on quantitative colorimetric principle.
The system has been shown to fulfill the requirements for measurement of propofol concentration in whole blood samples with precission and accuracy suitable for elucidating propofol pharmacokinetics at clinical relavant concentration with no requirement for sample preparation and a fast time to results. The analysis offers the opportunity to study propofol blood concentrations in real time at the bedside of the patient
|- Main changes (audit trail)|
|- RECORD||15-mei-2013 - 23-mei-2013|