COMparative Performance of General Purpose Models
ConditionNeurosurgical Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
About this trial
To compare the performance of the Eleveld models for propofol and remifentanil on neurosurgery patients admitted to intensive care with their intraoperative performance.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients undergoing elective neurosurgical procedures with an expected sedation after surgery of > 12 hours • Requirement for an arterial line
Disqualifiers
Pregnancy
Known sensitivity or allergy to propofol or remifentanil
Patient participating in research for which a period of exclusion is currently required by other study protocol, ethical committee or health authority.
Age < 18 years old
Trial population
Adult patients undergoing elective neurosurgical procedures with an expected sedation after surgery of \> 12 hours
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
MdAPE difference for propofol
The difference in MdAPE will be measured when comparing the model performance for propofol in the ICU to the intraoperative phase.
Time frame
october 20242
MdAPE difference for remifentanil
The difference in MdAPE will be measured when comparing the model performance for remifentanil in the ICU to the intraoperative phase.
Time frame
october 2024Secondary outcomes
1
Propofol and remifentanil metabolites
Metabolites of propofol and remifentanil (4-hydroxy propofol and remifentanil acid) during infusion
Time frame
october 20242
BIS profile
Bispectral index monitor profile during infusion (min = 0, max = 100)
Time frame
october 20243
NOL profile
NOL (Nociceptive Level) value (min = 0, max = 100)
Time frame
Oct 20244
RASS
RASS measurements during infusion (min = -5, max = +4).
Time frame
october 2024Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Lead sponsor
University Medical Center Groningen
Collaborator
Source ClinicalTrials.gov