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OpenTrials
Completed

NCT Number: NCT02608775

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Brussel

Jette, 1090, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Metrodoloris Medical System

Device

Application of a skin electrode

Other names: ANI monitor

Aisys® care station, Acertys

Device

Standard photoplethysmography

Other names: SPI monitor

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2015
Registry last updated
Aug 17, 2016

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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