Status:

COMPLETED

The TI.VA Algorithm: A First-in-Humans Test.

Lead Sponsor:

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Conditions:

Anesthesia

Eligibility:

All Genders

18-65 years

Phase:

NA

Brief Summary

The TI.VA algorithm is a new method to titrate the anesthetic drug concentrations whenever the planned level of anesthesia results to be not appropriate to blunt the patient's reaction to surgical sti...

Detailed Description

The TI.VA algorithm is a new method to titrate the anesthetic drug concentrations whenever the planned level of anesthesia results to be not appropriate to blunt the patient's reaction to surgical sti...

Eligibility Criteria

Inclusion

  • The inclusion criteria were: :
  • age 18-65 years at the time of recruitment.
  • candidates for curative surgery for breast cancer.
  • American Society of Anaesthesiologists (ASA) status I/II.
  • The exclusion criteria were:
  • ASA status \> II.
  • counter-indications for use of the drugs employed in this protocol.
  • pregnancy or lactation.
  • incapacity to understand the study explanation and sign the informed consent form.
  • These criteria were selected according to the risk mitigation strategy described in the protocol.

Exclusion

    Key Trial Info

    Start Date :

    December 1 2020

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 31 2021

    Estimated Enrollment :

    5 Patients enrolled

    Trial Details

    Trial ID

    NCT05199883

    Start Date

    December 1 2020

    End Date

    January 31 2021

    Last Update

    February 3 2022

    Active Locations (1)

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    Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Italy, 20133