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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pain Tachycardia Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Metrodoloris Medical System

Application of a skin electrode

Group Type EXPERIMENTAL

Metrodoloris Medical System

Intervention Type DEVICE

Application of a skin electrode

Aisys® care station, Acertys

Intervention Type DEVICE

Standard photoplethysmography

Aisys® care station, Acertys

SPI calculated from photoplethysmography

Group Type ACTIVE_COMPARATOR

Metrodoloris Medical System

Intervention Type DEVICE

Application of a skin electrode

Aisys® care station, Acertys

Intervention Type DEVICE

Standard photoplethysmography

Interventions

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Metrodoloris Medical System

Application of a skin electrode

Intervention Type DEVICE

Aisys® care station, Acertys

Standard photoplethysmography

Intervention Type DEVICE

Other Intervention Names

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ANI monitor SPI monitor

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No