COMparative Performance of General Purpose Models
1 other identifier
observational
42
1 country
2
Brief Summary
To compare the performance of the Eleveld models for propofol and remifentanil on neurosurgery patients admitted to intensive care with their intraoperative performance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2024
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2024
CompletedFirst Posted
Study publicly available on registry
September 4, 2024
CompletedStudy Start
First participant enrolled
October 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
February 12, 2026
February 1, 2026
2 years
July 10, 2024
February 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
october 2024
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.
october 2024
Secondary Outcomes (4)
Propofol and remifentanil metabolites
october 2024
BIS profile
october 2024
NOL profile
Oct 2024
RASS
october 2024
Eligibility Criteria
Adult patients undergoing elective neurosurgical procedures with an expected sedation after surgery of \> 12 hours
You may qualify if:
- Adult patients undergoing elective neurosurgical procedures with an expected sedation after surgery of \> 12 hours • Requirement for an arterial line
You may not qualify if:
- Pregnancy
- Known sensitivity or allergy to propofol or remifentanil
- Age \< 18 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Foundation IRCCS Carlo Besta Neurological Institute
Milan, Italy, 20133, Italy
Fondazione IRCCS Istituto Neurologico C. Besta
Milan, Milano, 20133, Italy
Study Officials
- PRINCIPAL INVESTIGATOR
Michele Introna, M.d.
Fondazione IRCCS Istituto Neurologico C. Besta
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2024
First Posted
September 4, 2024
Study Start
October 2, 2024
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 12, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
Propofol and remifentanil pharmacokinetic and pharmacodynamic data.