Describe Relations Between qCON and qNOX Indicies During Propofol-Remifentanil General Anesthesia

April 24, 2024 updated by: Federico Linassi, University of Padova

Describe Relationship Between qCON and qNOX of the CONOX Monitor During General Anesthesia Perfromed With Propofol and Remifentanil Target Controlled Infusion (TCI)

CONOX is a neuromonitoring EEG- device for sedation (qCON) and analgesia (qNOX) monitoring during general anesthesia.

It is unknown on how the indicies can differentiate themselves so aim of this study is to determine the relationship bewtween the 2 indicies.

Study Overview

Status

Recruiting

Conditions

Detailed Description

CONOX is a neuromonitoring EEG- device for sedation (qCON) and analgesia (qNOX) monitoring during general anesthesia.

It is unknown on how the indicies can differentiate themselves so aim of this study is to determine the relationship bwtween the 2 indicies, as well as with EMG, Concentration of Propofol (CeP) and Remifentanil (CeR) during Total Intravenous Anesthesia with Target Controlled Infusion (TIVA-TCI).

Study Type

Observational

Enrollment (Estimated)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Women undergoing brast cancer surgery with general anesthesia with Propofol and Remifentanil TCI will be recruited

Description

Inclusion Criteria:

  • Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld or Schnider model) and Remifentanil (Minto model) and CONOX monitoring

Exclusion Criteria:

  • Neurological disease
  • Psychiatric disease
  • Obesity
  • Locoregional anesthesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between qCON and qNOX
Time Frame: CONOX values will be recorded from start of anesthesia to the return of responsiveness at the end of surgery
qCON and qNOX values from CONOX monitor will be compared
CONOX values will be recorded from start of anesthesia to the return of responsiveness at the end of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between qCON and concentrations of Propofol(CeP)
Time Frame: CONOX and TCI values will be recorded from start of anesthesia to the return of responsiveness at the end of surgery
qCON and CeP values from CONOX monitor and infusion pump will be compared
CONOX and TCI values will be recorded from start of anesthesia to the return of responsiveness at the end of surgery
Correlation between qNOX and concentrations of Remifentanil (CeR)
Time Frame: CONOX and TCI values will be recorded from start of anesthesia to the return of responsiveness at the end of surgery
qNOX and CeR values from CONOX monitor and infusion pump will be compared
CONOX and TCI values will be recorded from start of anesthesia to the return of responsiveness at the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

March 24, 2024

First Submitted That Met QC Criteria

March 29, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CONOXBird

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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