Re-evaluation of the Effect Site Model of the PKPD Propofol Eleveld Model

NCT06417645 | Recruiting Phase 4

• 1 other identifier: CEC-SSLR ord: 459
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Surgery

Keywords

propofol, Eleveld, BIS, predicted effect site model, non-lineal behavior

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• evaluation of the evolution of the EEG frequency bands

  anesthesia

Study Arms (1)

BIS predicted vs real

EXPERIMENTAL

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.

Drug: fixed propofol infusion 15 mg/kg/h until 1% BSR (burst suppression ratio)

Interventions

fixed propofol infusion 15 mg/kg/h until 1% BSR (burst suppression ratio) DRUG

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.

BIS predicted vs real

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II patients between 18 and 60 years of age, who undergo elective surgery in the central ward of the Hospital Base San José Osorno, Chile. Consecutive patients from the beginning of the study up to 12 months from the admission of the first patient.

You may not qualify if:

• Emergency surgery patient.
• Patients with dementia, delirium or altered state of consciousness.
• Full stomach or risk of aspiration.
• Allergic to propofol.

Sponsors & Collaborators

• Universidad del Desarrollo: lead
• Technical University of Munich: collaborator

Study Sites (1)

Hospital Base san José de Osorno

Osorno, Chile

RECRUITING

Related Publications (2)

• 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.

  PMID: 23040653 BACKGROUND

• 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.

  PMID: 29661412 RESULT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Med

Model Details: healthy patients proposed for elective surgery longer than 60 min, received a standard protocol TCI iv anesthesia with EEG BIS index monitoring

Study Record Dates

• First Submitted: May 11, 2024
• First Posted: May 16, 2024
• Study Start: September 1, 2013
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)