Usefulness and Predictive Capacity of ANI and SPI of the Hemodynamic Response
Primary Purpose
Pain, Tachycardia, Hypertension
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Metrodoloris Medical System
Aisys® care station, Acertys
Sponsored by
About this trial
This is an interventional prevention trial for Pain focused on measuring ANI, SPI, Autonomic balance, Nociception measurement
Eligibility 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
Sites / Locations
- UZ Brussel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Metrodoloris Medical System
Aisys® care station, Acertys
Arm Description
Application of a skin electrode
SPI calculated from photoplethysmography
Outcomes
Primary Outcome Measures
The influence of a standardized noxious stimulus on pain measurement by means of analgesia nociception index (numerical score 0-100)
dimensionless number
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02608775
First Posted
November 5, 2015
Last Updated
August 16, 2016
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT02608775
Brief Title
Usefulness and Predictive Capacity of ANI and SPI of the Hemodynamic Response
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 Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Tachycardia, Hypertension
Keywords
ANI, SPI, Autonomic balance, Nociception measurement
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metrodoloris Medical System
Arm Type
Experimental
Arm Description
Application of a skin electrode
Arm Title
Aisys® care station, Acertys
Arm Type
Active Comparator
Arm Description
SPI calculated from photoplethysmography
Intervention Type
Device
Intervention Name(s)
Metrodoloris Medical System
Other Intervention Name(s)
ANI monitor
Intervention Description
Application of a skin electrode
Intervention Type
Device
Intervention Name(s)
Aisys® care station, Acertys
Other Intervention Name(s)
SPI monitor
Intervention Description
Standard photoplethysmography
Primary Outcome Measure Information:
Title
The influence of a standardized noxious stimulus on pain measurement by means of analgesia nociception index (numerical score 0-100)
Description
dimensionless number
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
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)
Description
Comparing the ANI and SPI before and during possible hemodynamic reactivity
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stef Cornelis, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Caroline Vanlersberghe, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jan Poelaert, Prof. MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Study Chair
Facility Information:
Facility Name
UZ Brussel
City
Jette
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
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Usefulness and Predictive Capacity of ANI and SPI of the Hemodynamic Response
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