Correlation Between qNOX and Analgesia Nociception Index (ANI) Values During General Anesthesia (ANI)

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

Correlation Between qNOX Values of the CONOX Monitor and Analgesia Nociception Index (ANI) Values During General Anesthesia Conducted With Propofol and Remifentanil TCI

qNOX and ANI are two indexes evaluting the analgesia conduction during general anesthesia.

No trials have compared them, so with this trial authors want to explore the correlations between them.

Study Overview

Status

Recruiting

Conditions

Detailed Description

qNOX and ANI are two indexes evaluting the anaglesia conduction during general anesthesia.

Even if the aim is the same (to measure the nociception level) these indexes utilize different algorithm: the qNOX is derived by the electroencephalogrm (EEG), the ANI is derived by heart rate variation.

No trials have compared them, so with this trial authors want to explore the correlations between them, and if altered values of one of them is stronger related to postoperative pain and delirium.

Study Type

Observational

Enrollment (Estimated)

40

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

N/A

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 model) and remifentanil (Eleveld model)

Exclusion Criteria:

  • Neurological disease
  • Psychiatric disease
  • Obesity
  • Regional anesthesia performed

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 qNOX and ANI values
Time Frame: qNOX, ANI , as well as remifentanil concentration recorded during induction, intubation and maintenance phase of general anesthesia detected with target controlled inusion will be paired.
qNOX and ANI values will be compared to check the correspondance in evaluting analgesia level
qNOX, ANI , as well as remifentanil concentration recorded during induction, intubation and maintenance phase of general anesthesia detected with target controlled inusion will be paired.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between qNOX from CONOX and Analgesia nocicpetion index (ANI) values and postoperative pain
Time Frame: qNOX, ANI and remifentanil concentrations recorded during induction, intubation and maintenance phase of general anesthesia will be related to postoperative pain, evalued with NRS score after 24 hours
Evaluate if qNOX or ANI values relate to postoperative pain
qNOX, ANI and remifentanil concentrations recorded during induction, intubation and maintenance phase of general anesthesia will be related to postoperative pain, evalued with NRS score after 24 hours
Correlation between qNOX from CONOX and analgesia nocicpetion index (ANI) values and postoperative delirium
Time Frame: qNOX, ANI and remifentanil concentrations recorded during induction, intubation and maintenance phase of general anesthesia will be related to postoperative delirium, evaluated with CAM and 4AT score after 24 hours
Evaluate if qNOX or ANI values relate to postoperative delirium
qNOX, ANI and remifentanil concentrations recorded during induction, intubation and maintenance phase of general anesthesia will be related to postoperative delirium, evaluated with CAM and 4AT score after 24 hours

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 2, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

March 29, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOXANI

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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