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Completed

NCT Number: NCT06351072

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

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.

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Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Treviso Regional Hospital

Treviso, TV, 31100, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Correlation between qNOX and ANI values

    Time frame: qNOX, ANI, pupoillometry values, propofol and remifentanil concentration during induction, intubation, after post-tetanic count at the trend-of-four 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

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

Acronym: ANI

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2024
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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