Status:

RECRUITING

COMparative Performance of General Purpose Models

Lead Sponsor:

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Collaborating Sponsors:

University Medical Center Groningen

Conditions:

Neurosurgical Patients

Eligibility:

All Genders

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.

Detailed Description

Despite the widespread adoption of Target Controlled Infusion (TCI) models in modern clinical anesthesia practice, much less attention has been paid in the literature to their potential applications i...

Eligibility Criteria

Inclusion

  • Adult patients undergoing elective neurosurgical procedures with an expected sedation after surgery of \> 12 hours • Requirement for an arterial line

Exclusion

  • 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
  • Patients subjected to infusion of propofol and/or remifentanil not delivered through TCI pumps before the inclusion
  • Patients exposed to other sedatives (benzodiazepines, volatile anesthetics, quetiapine) before the inclusion

Key Trial Info

Start Date :

October 2 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

42 Patients enrolled

Trial Details

Trial ID

NCT06584097

Start Date

October 2 2024

End Date

December 31 2026

Last Update

October 22 2024

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Foundation IRCCS Carlo Besta Neurological Institute

Milan, Italy, Italy, 20133

2

Fondazione IRCCS Istituto Neurologico C. Besta

Milan, Milano, Italy, 20133