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

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.

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.

Study Overview

• Status: Completed
• Conditions: Pain; Hypertension; Tachycardia
• Intervention / Treatment: Device: Metrodoloris Medical System; Device: Aisys® care station, Acertys

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Jette, Belgium, 1090
    • UZ Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: November 5, 2015
• First Submitted That Met QC Criteria: November 16, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Estimate): August 17, 2016
• Last Update Submitted That Met QC Criteria: August 16, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: SPI; ANI; Autonomic balance; Nociception measurement
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia
• Other Study ID Numbers: ANI