Usefulness and Predictive Capacity of ANI and SPI of the Hemodynamic Response

Study Overview
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Brief Summary
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The primary objective of this study is to investigate the influence of a standardized noxious stimulus on the ANI, SPI and hemodynamic parameters during standard propofol and sufentanil TCI and to see if the ANI and SPI are predictive of a hemodynamic reaction. In addition the investigators compare the performance of ANI and SPI against one another as well as investigate if ANI or SPI can be used to find the ideal CeSUF for a given patient.

Detailed Description
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During general anesthesia hypnosis can be monitored routinely using EEG derivates like Bispectral index (BIS), entropy,.… However, monitoring analgesia or more precisely the nociceptive-antinociceptive (analgetic) balance during anesthesia proved more difficult. Clinical signs such as heart rate (tachycardia) or blood pressure (hypertension) are usually observed and used to assess nociception and a patient's autonomic unbalance. During general anesthesia administration of opioids like sufentanil and remifentanil decrease the ANS reactivity to noxious stimulation. Recently two variables based on standard anesthesia monitor equipment have been introduced into clinical practice: the Analgesia Nociception Index (ANI), derived from analysis of the small beat-to-beat oscillations of the heart rate during respiration, the heart rate variability (HRV), and the Surgical Pleth Index (SPI), calculated from the plethysmographic amplitude and heart beat interval.

Official Title
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Usefulness and Predictive Capacity of ANI and SPI of the Hemodynamic Response to Standardized Stimuli During Neuro- and Urologic Surgery Under Standard Target Controlled Infusion of Propofol and Sufentanil.

Conditions
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Pain, Tachycardia, Hypertension

Intervention / Treatment
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* Device: Metrodoloris Medical System
* Device: Aisys® care station, Acertys


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male non-pregnant female participants ASA II-III >18-65 years Weight not exceeding 30% under or above ideal body weight Elective intracranial surgery or circumcision. Exclusion Criteria: Use concurrent opioid containing drugs Use of any autonomic nervous system altering drugs History of opioid or alcohol abuse Hepatic, renal, metabolic, neuromuscular or cardiovascular disease Known allergies to anesthestetic / analgesic drugs Use of a peripheral nerve block, penile block

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metrodoloris Medical System<br>Application of a skin electrode | Device: Metrodoloris Medical System<br>* Application of a skin electrode<br>* Other names: ANI monitor;Device: Aisys® care station, Acertys<br>* Standard photoplethysmography<br>* Other names: SPI monitor;|
| Active Comparator: Aisys® care station, Acertys<br>SPI calculated from photoplethysmography | Device: Metrodoloris Medical System<br>* Application of a skin electrode<br>* Other names: ANI monitor;Device: Aisys® care station, Acertys<br>* Standard photoplethysmography<br>* Other names: SPI monitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The influence of a standardized noxious stimulus on pain measurement by means of analgesia nociception index (numerical score 0-100) | dimensionless number | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive capacity of ANI and SPI of hemodynamic reactivity by means of analgesia nociception index (numerical score 0-100) or by SPI (numerical index 100-0) | Comparing the ANI and SPI before and during possible hemodynamic reactivity | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ANI, SPI, Autonomic balance, Nociception measurement