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

Not Applicable

Completed

• Conditions: Pain; Hypertension; Tachycardia
• Interventions: Device: Metrodoloris Medical System; Device: Aisys® care station, Acertys

• Registration Number: NCT02608775
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-11-05
• Study First Submitted QC: 2015-11-16
• Study First Posted: 2015-11-20
• Study Start: 2016-01
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metrodoloris Medical System	Metrodoloris Medical System	Application of a skin electrode
Aisys® care station, Acertys	Metrodoloris Medical System	SPI calculated from photoplethysmography
Metrodoloris Medical System	Aisys® care station, Acertys	Application of a skin electrode
Aisys® care station, Acertys	Aisys® care station, Acertys	SPI calculated from photoplethysmography

Primary Outcome Measures

Name	Time	Method
The influence of a standardized noxious stimulus on pain measurement by means of analgesia nociception index (numerical score 0-100)	30 minutes	dimensionless number

Secondary Outcome Measures

Name	Time	Method
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)	30 minutes	Comparing the ANI and SPI before and during possible hemodynamic reactivity

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Jette, Belgium