|- candidate number||28529|
|- NTR Number||NTR7011|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-feb-2018|
|- Secondary IDs||201800065 UMCG Research Register|
|- Public Title||Bayesian-based propofol infusion advisory tool validation |
|- Scientific Title||The accuracy and clinical feasibility of a Bayesian-based, patient-individualized, pharmacodynamic advisory system to optimize propofol administration using the qCON index as a controlled variable. A comparison versus standard of care. |
|- hypothesis||To assess the accuracy and the clinical feasibility of a Bayesian-based, patient-individualized, pharmacodynamic advisory system to optimize propofol effect-compartment-controlled administration using the qCON index as a controlled variable versus qCON-guided effect-compartment controlled propofol administration without the input of the advisory system.|
|- Healt Condition(s) or Problem(s) studied|| Anesthesiology, Propofol|
|- Inclusion criteria||• 18 years or older |
• American Society of Anesthesiology (ASA) Classification 1-4
• Elective surgery under general anaesthesia with propofol
• Surgery duration longer than one hour
|- Exclusion criteria||• The use of psycho-active drugs|
• Alcohol or recreative drug abuse
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2018|
|- planned closingdate||1-okt-2019|
|- Target number of participants||100|
|- Interventions||target controlled propofol infusion with and without advisory tool.|
|- Primary outcome||the percentage of case time the qCON remains between 40 and 60. |
|- Secondary outcome||• time until loss of consciousness (LOC) from the start of propofol infusion and the amount of propofol used during induction. |
• The control performance during induction will be studied taking into account the following parameters :
• qCONLOC = qCON at the moment of LOC.
• TqCON TARGET = observed time required for reaching the target qCON range between 40 and 60.
• TPEAK, qCON = observed time required for reaching maximal drug effect (lowest qCON value).
• qCONPEAK = observed qCON value at tPEAK, qCON.
• TEQ = observed time required for finally reaching the target range between 40 and 60 with or without overshoot, also called time to steady-state.
|- Timepoints||Continues registration of required parameters for advisory tool from start of anesthesia induction till the end of propofol infusion.
Also, during recovery, we will compare the time from stop propofol infusion until opening of the eyes on command and orientation. Hereby, orientation will be defined as saying name and date of birth on request.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| R. Spanjersberg|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. M.M.R.F. Struys|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|University Medical Center Groningen (UMCG)|
|- Brief summary||Target-controlled infusion has been developed towards a mature technology routinely used in clinical practice to target plasma and effect-site concentration for drug infusion such as propofol, instead of volumetric infusion using inaccurate units per hour. The cerebral drug effect is routine measured by a “depth of anaesthesia monitor”, based on a processed EEG system, such as the qCON (Fresenius, Brésins, France). Nowadays, the anesthesiologist has to combine the independent information from the propofol effect-site concentration on the pump display and the qCON index from the EEG monitor to make an accurate decision in order to optimize drug administration. However, the effect-site concentration can be linked to effect as measured by qCON and can be modelled in an sigmoidal “E-max” curve. This could allow the clinician to observe the combined information in an advisory display.
As the relationship between effect-site concentration of propofol and qCON is dynamically and continuously changing over time, a computer algorithm could be helpful to personalise the sigmoidal “Emax” curve on the advisory display towards the individual patient and his/her condition (e.g. other drugs given simultaneously during propofol-based anesthesia). Adjusting predictions using prior information, based on measurements, could continuously update the E-max curve. This can be done by applying Bayesian-adjustment implemented in an advisory tool that provides dose titration advices for the clinician aiming to reach a corresponding preset desired qCON value in a continuous matter.
|- Main changes (audit trail)|
|- RECORD||5-feb-2018 - 18-feb-2018|