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NCT06351072 Clinical Trial

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

Analgesia Clinical Trial

— ANI  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06351072
Other study ID # NOXANI
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 2, 2024
Est. completion date October 1, 2024

Study information
Verified date April 2024
Source University of Padova
Contact Federico Linassi, MD
Phone 0422322444
Email federico.linassi@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date October 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers
Gender Female
Age group 18 Years to 90 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Treviso Regional Hospital Treviso TV

Sponsors (1)
Lead Sponsor Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation between qNOX and ANI values 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 Correlation between qNOX from CONOX and Analgesia nocicpetion index (ANI) values and postoperative pain 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
Secondary Correlation between qNOX from CONOX and analgesia nocicpetion index (ANI) values and postoperative delirium 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
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