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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02608775

Enrollment

Registered

2015-11-20

Start date

2016-01-31

Completion date

2016-06-30

Last updated

2016-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Pain, Tachycardia

Keywords

ANI, SPI, Autonomic balance, Nociception measurement

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.

Interventions

DEVICEMetrodoloris Medical System

Application of a skin electrode

DEVICEAisys® care station, Acertys

Standard photoplethysmography

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026