PainNCT02608775
Usefulness and Predictive Capacity of ANI and SPI of the Hemodynamic Response
A study testing Metrodoloris Medical System and Aisys® care station, Acertys in people with Pain and Tachycardia, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Tachycardia, Hypertension
- What is being tested?
- Metrodoloris Medical System and Aisys® care station, Acertys
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2016to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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
- Being tested
- Metrodoloris Medical System, Aisys® care station, Acertys
- Keywords
- ANI, SPI, Autonomic balance, Nociception measurement
- Medical subject headings
- Pain, Tachycardia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metrodoloris Medical SystemDevice
Also called ANI monitor
Application of a skin electrode
Aisys® care station, AcertysDevice
Also called SPI monitor
Standard photoplethysmography
| Study group | Role | What they receive |
|---|---|---|
| Metrodoloris Medical System | Experimental | Application of a skin electrode Receives: Device: Metrodoloris Medical System; Device: Aisys® care station, Acertys |
| Aisys® care station, Acertys | Active comparator | SPI calculated from photoplethysmography Receives: Device: Metrodoloris Medical System; Device: Aisys® care station, Acertys |
What is being measured
The primary outcome is the main question the study is designed to answer.
The influence of a standardized noxious stimulus on pain measurement by means of analgesia nociception index (numerical score 0-100)
dimensionless number
Measured: 30 minutes
Secondary outcomes (1)
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
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veerle Van Mossevelde, Universitair Ziekenhuis Brussel
- Investigators
- Stef Cornelis, MD, Principal investigator, Universitair Ziekenhuis BrusselCaroline Vanlersberghe, MD, Study director, Universitair Ziekenhuis BrusselJan Poelaert, Prof. MD, Study chair, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608775
- Sponsor's protocol ID
- ANI
- Status last verified
- Aug 2016
- First submitted
- 5 Nov 2015
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02608775
- Acronym / sponsor ID
- ANI
- Conditions
- Pain, Tachycardia, Hypertension
- Keywords
- ANI, SPI, Autonomic balance, Nociception measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metrodoloris Medical System | Experimental | Device: Metrodoloris Medical System, Device: Aisys® care station, AcertysApplication of a skin electrode |
| Aisys® care station, Acertys | Active comparator | Device: Metrodoloris Medical System, Device: Aisys® care station, AcertysSPI calculated from photoplethysmography |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male
- non-pregnant female participants
- ASA II-III
- >18-65 years
- Weight not exceeding 30% under or above ideal body weight
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metrodoloris Medical SystemAlso: ANI monitorApplication of a skin electrode | Device | Aisys® care station, Acertys, Metrodoloris Medical System |
| Aisys® care station, AcertysAlso: SPI monitorStandard photoplethysmography | Device | Aisys® care station, Acertys, Metrodoloris Medical System |
Primary outcome
The influence of a standardized noxious stimulus on pain measurement by means of analgesia nociception index (numerical score 0-100)
Time frame: 30 minutes
dimensionless number
1 secondary outcome
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)
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stef Cornelis, MD principal investigator
Universitair Ziekenhuis Brussel
Caroline Vanlersberghe, MD study director
Universitair Ziekenhuis Brussel
Jan Poelaert, Prof. MD study chair
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metrodoloris Medical System and Aisys® care station, Acertys in people with Pain and Tachycardia, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The influence of a standardized noxious stimulus on pain measurement by means of analgesia nociception index (numerical score 0-100) (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.