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

Hypertension Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608775
• Other study ID #: ANI
• Status: Completed
• Phase: N/A
• First received: November 5, 2015
• Last updated: August 16, 2016
• Start date: January 2016
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypertension
• Pain
• Tachycardia

Intervention

Device:
• Metrodoloris Medical System
Application of a skin electrode
• Aisys® care station, Acertys
Standard photoplethysmography

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The influence of a standardized noxious stimulus on pain measurement by means of analgesia nociception index (numerical score 0-100)	dimensionless number	30 minutes	Yes
Secondary	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)	Comparing the ANI and SPI before and during possible hemodynamic reactivity	30 minutes	Yes