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

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ClinicalTrials.gov Identifier: NCT02608775
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : August 17, 2016
Sponsor:
Information provided by (Responsible Party):
Veerle Van Mossevelde, Universitair Ziekenhuis Brussel

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pain Tachycardia Hypertension Device: Metrodoloris Medical System Device: Aisys® care station, Acertys Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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.
Study Start Date : January 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Metrodoloris Medical System
Application of a skin electrode
Device: Metrodoloris Medical System
Application of a skin electrode
Other Name: ANI monitor

Device: Aisys® care station, Acertys
Standard photoplethysmography
Other Name: SPI monitor

Active Comparator: Aisys® care station, Acertys
SPI calculated from photoplethysmography
Device: Metrodoloris Medical System
Application of a skin electrode
Other Name: ANI monitor

Device: Aisys® care station, Acertys
Standard photoplethysmography
Other Name: SPI monitor




Primary Outcome Measures :
  1. The influence of a standardized noxious stimulus on pain measurement by means of analgesia nociception index (numerical score 0-100) [ Time Frame: 30 minutes ]
    dimensionless number


Secondary Outcome Measures :
  1. 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) [ Time Frame: 30 minutes ]
    Comparing the ANI and SPI before and during possible hemodynamic reactivity



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608775


Locations
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Belgium
UZ Brussel
Jette, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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Principal Investigator: Stef Cornelis, MD Universitair Ziekenhuis Brussel
Study Director: Caroline Vanlersberghe, MD Universitair Ziekenhuis Brussel
Study Chair: Jan Poelaert, Prof. MD Universitair Ziekenhuis Brussel

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Responsible Party: Veerle Van Mossevelde, Data Nurse, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT02608775    
Other Study ID Numbers: ANI
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016
Keywords provided by Veerle Van Mossevelde, Universitair Ziekenhuis Brussel:
ANI
SPI
Autonomic balance
Nociception measurement
Additional relevant MeSH terms:
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Tachycardia
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiac Conduction System Disease
Pathologic Processes