NCT06417645|UnknownPhase 4
Re-evaluation of the Effect Site Model of the PKPD Propofol Eleveld Model
Eleved PD
the BIS Index Response is Poorly Described by Propofol Effect Site Eleveld's Model After Applying a Perturbation
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Eleved PD
the BIS Index Response is Poorly Described by Propofol Effect Site Eleveld's Model After Applying a Perturbation
Sponsor study identifier
interventional
24
1 country
1
Study Start
September 1, 2013
Actual (reported)Primary Completion
September 15, 2023
Actual (reported)Study Completion
September 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
in healthy patients undergoing elective surgery, after a very slow induction, using Eleveld's kinetics as a reference, after loss of consciousness (LOC) and intubation, proceed to infuse propofol until 1% burst suppression ratio is obtained. Then return to the LOC concentration. The BISindex predicted by the model and the real one will be evaluated. The evolution of spectral density frequencies over time will also be evaluated.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2013
Actual (reported)September 15, 2023
Actual (reported)May 11, 2024
Actual (reported)May 16, 2024
Actual (reported)September 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
predicted BIS index vs real BIS index
we compare the BIS predicted from the Eleveld model vs the response of our patients uring all the anesthesia procedure
anesthesia
evaluation of the evolution of the EEG frequency bands
anesthesia
After slow propofol induction and standard monitoring with BIS EEG monitor. The propofol infusion guided by iTIVA simulator (Android / iOS) using Eleveld kinetic model. LOC (defined as loss of response to loud call and shoulder movement-touch), the same concentration of propofol will be maintained for 5 minutes to assess EEG stability. .Intubation will proceed as usual, starting remifentanil at 4.5 ng/ml and rocuronium bromide 0.6 mg/kg. After 5 min and before the start of surgery, propofol will be infused at 15 mg/kg/h until 1% BSR is reached, observed on the BIS monitor, and then return to the rate that represents the LOC concentration. EEG data shall be retrieved from the BIS monitor via USB. Post hoc using the software tivatrainer.com we will simulate the Eleved calculated plasma concentration and the Bis prediction with our BIS real data.
after a slow induction with propofol to loss of consiousness (LOC), we proceed to give remifentanil TCI and rocuronium and intubate the patient. After 5 min we infuse 15 mg/kg/h until 1%BSR observe in the BIS monitor. Then we reduce the TCI LOC predicted concentration.
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Hospital Base san José de Osorno
Osorno, Chile
Sepulveda PO, Mora X. [Reevaluation of the time course of the effect of propofol described with the Schnider pharmacokinetic model]. Rev Esp Anestesiol Reanim. 2012 Dec;59(10):542-8. doi: 10.1016/j.redar.2012.07.019. Epub 2012 Oct 4. Spanish.
Eleveld DJ, Colin P, Absalom AR, Struys MMRF. Pharmacokinetic-pharmacodynamic model for propofol for broad application in anaesthesia and sedation. Br J Anaesth. 2018 May;120(5):942-959. doi: 10.1016/j.bja.2018.01.018. Epub 2018 Mar 12.
First Submitted
May 11, 2024
First Posted
May 16, 2024
Study Start
September 1, 2013
Actual (reported)Primary Completion
Cross-reactive Immunity Elicited by Oral and Parenteral Typhoid Vaccines
Contact the study team to confirm eligibility.
September 15, 2023
Actual (reported)Study Completion
September 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 16, 2024
Record last verified: 2024-05
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