NCT02608775

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Tachycardia
• Hypertension

Interventions

Type	Name	Description
DEVICE	Metrodoloris Medical System	Application of a skin electrode
DEVICE	Aisys® care station, Acertys	Standard photoplethysmography

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-11-20
• Last updated: 2016-08-17

Locations

1 site across 1 country: Belgium