Nociceptive PainANI-MICINCT03749304
Monitoring Analgesia by ANI (Analgesia The Nociception Index)
A study testing ANI monitor in people with Nociceptive Pain and Surgical Procedure, Unspecified, run by University Hospital, Lille at 1 site in France.
Trial summary
The objective of this research is to study the variations of the ANI(Analgesia The Nociception Index) according to 2 periods: the "NoStim" period before surgical incision under general anesthesia and the period of hemodynamic reactivity "ReactHemo" peroperative. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nociceptive Pain, Surgical Procedure, Unspecified
- What is being tested?
- ANI monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2014to Mar 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with IBD
- Scheduled surgery: laparotomy or laparoscopic resection with high risk of laparo-conversion
Who cannot join
- patient included in another current study or the previous month
- urgent surgery
- toxicomania or receiving opioids preoperatively
- pregnant woman
- psychosis
- betablocker treatment
Show all 9Show fewer
- diabetic dysautonomia
- non-sinus heart rate
- pacemaker heart transplant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring Analgesia by ANI (Analgesia The Nociception Index) During Surgery Inflammatory Bowel
The objective of this research is to study the variations of the ANI(Analgesia The Nociception Index) according to 2 periods: the "NoStim" period before surgical incision under general anesthesia and the period of hemodynamic reactivity "ReactHemo" peroperative. This period is defined by a 20% increase in FC and / or PAS (the only gold standard today).
- Conditions
- Nociceptive Pain, Surgical Procedure, Unspecified
- Being tested
- ANI monitor
- Medical subject headings
- Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANI monitorDevice
experimental medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index
| Study group | Role | What they receive |
|---|---|---|
| ANI monitor | Experimental | Not described Receives: Device: ANI monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of ANI greater than 20 points
ANI decrease greater than 20 points between a "NoStim" period before surgical incision under general anesthesia and a period of intraoperative "ReactHemo" hemodynamic reactivity defined by a 20% increase in FC and / or PAS.
Measured: During the surgery, an average Three hours and a half
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start16 Mar 2014
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nociceptive PainStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Lebuffe, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749304
- Sponsor's protocol ID
- 2012_31
- Other IDs
- 2012-A01363-40
- Acronym
- ANI-MICI
- Status last verified
- Nov 2018
- First submitted
- 20 Nov 2018
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Analgesia by ANI (Analgesia The Nociception Index) During Surgery Inflammatory Bowel
- ClinicalTrials.gov ID
- NCT03749304
- Acronym / sponsor ID
- ANI-MICI / 2012_31
- Conditions
- Nociceptive Pain, Surgical Procedure, Unspecified
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 16 Mar 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 21 Nov 2018 (actual)
- 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 objective of this research is to study the variations of the ANI(Analgesia The Nociception Index) according to 2 periods: the "NoStim" period before surgical incision under general anesthesia and the period of hemodynamic reactivity "ReactHemo" peroperative. This period is defined by a 20% increase in FC and / or PAS (the only gold standard today).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ANI monitor | Experimental | Device: ANI monitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient with IBD
- Scheduled surgery: laparotomy or laparoscopic resection with high risk of laparo-conversion
Key exclusion criteria (9 listed)
- patient included in another current study or the previous month
- urgent surgery
- toxicomania or receiving opioids preoperatively
- pregnant woman
- psychosis
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 |
|---|---|---|
| ANI monitorexperimental medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index | Device | ANI monitor |
Primary outcome
Change of ANI greater than 20 points
Time frame: During the surgery, an average Three hours and a half
ANI decrease greater than 20 points between a "NoStim" period before surgical incision under general anesthesia and a period of intraoperative "ReactHemo" hemodynamic reactivity defined by a 20% increase in FC and / or PAS.
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 26 Nov 2018.
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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.
Gilles Lebuffe, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANI monitor in people with Nociceptive Pain and Surgical Procedure, Unspecified, run by University Hospital, Lille at 1 site in France.
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 2 inclusion and 9 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 26 Nov 2018. 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 France. 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?
Change of ANI greater than 20 points (time frame: During the surgery, an average Three hours and a half). 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 26 Nov 2018.