Clinical trial NCT02608775: Usefulness and Predictive Capacity of ANI and SPI of the Hemodynamic Response
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Tachycardia
Hypertension
Keywords: ANI
SPI
Autonomic balance
Nociception measurement
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: The influence of a standardized noxious stimulus on pain measurement by means of analgesia nociception index (numerical score 0-100)
timeFrame: 30 minutes
Secondary outcomes:
measure: 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)
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Stef Cornelis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Brussel
name: Caroline Vanlersberghe, MD
role: STUDY_DIRECTOR
affiliation: Universitair Ziekenhuis Brussel
name: Jan Poelaert, Prof. MD
role: STUDY_CHAIR
References: