Nociceptive PainANI-LOOPNCT03556696
Automatic Remifentanil Administration Guided by ANI During Propofol Anesthesia
A study testing ANI-REMI-loop, remifentanil pK/pD target administration device and Remifentanil in people with Nociceptive Pain and Surgical Procedure, Unspecified, run by University Hospital, Lille at 1 site in France.
Trial summary
Prospective Randomized Monocentric Clinical Trial during propofol anesthesia. The aim of the study is to test whether the use of a medical device designed to automatically administer remifentanil during surgery based on expert rules and continuous reading of heart rate, blood pressure and the Analgesia Nociception… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nociceptive Pain, Surgical Procedure, Unspecified
- What is being tested?
- ANI-REMI-loop, remifentanil pK/pD target administration device and Remifentanil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jun 2018to 22 Nov 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1, 2 or 3 adult patients scheduled to undergo burn wound surgery at the Burn Center of the University Hospital of Lille
Who cannot join
- BMI outside [17 - 35 kg/m2]
- pregnancy or breast feeding women
- non sinus cardiac rhythm
- documented dysautonomia
- complicated diabetes mellitus
- known allergy to a drug used in the clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Automatic Remifentanil Administration Guided by the Analgesia Nociception Index During Propofol Anesthesia
Prospective Randomized Monocentric Clinical Trial during propofol anesthesia. The aim of the study is to test whether the use of a medical device designed to automatically administer remifentanil during surgery based on expert rules and continuous reading of heart rate, blood pressure and the Analgesia Nociception Index results in lower overall remifentanil administration versus standard practice.
Read the detailed description
Prospective Randomized Monocentric Clinical Trial during propofol anesthesia.
- inclusion: ASA 1, 2 or 3 adult patients scheduled to undergo burn wound surgery in a Burn Center (University Hospital of Lille, France)
- arm 1 : Remifentanil will be automatically administered by an expert system guided by heart rate, blood pressure and the Analgesia Nociception Index (ANI).
- arm 2 : Remifentanil will be administered by a target controlled device using the Minto pK/pD model.
- propofol is administered throughout the procedure with a target controlled device using the pK/pD model of Schnider. The target will be guided by the BiSpectral index values.
- primary endpoint : overall normalized remifentanil administration.
- secondary endpoints : relative amount of time spent in a state of hemodynamic reactivity ; relative amount of time the ANI spends in the [0-50], [50-70] and [70-100] windows ; relative amount of time the BIS spends in the [0-40], [40-60] and [60-100] ; hemodynamic status at various times during anesthesia ; total amount of target modifications of remifentanil and propofol ; total amount of morphine administered in PACU ; total amount of ketamine administered in PACU ; incidence of nausea/vomiting in PACU ;
- Conditions
- Nociceptive Pain, Surgical Procedure, Unspecified
- Being tested
- ANI-REMI-loop, remifentanil pK/pD target administration device, Remifentanil, Propofol, ANI monitor
- Keywords
- general anesthesia, analgesia/nociception balance monitoring, expert system
- Medical subject headings
- Nociceptive Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANI-REMI-loopDevice
experimental medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index for automatic remifentanil administration
remifentanil pK/pD target administration deviceDevice
standard practice, remifentanil administration using Minto's pK/pD model
RemifentanilDrug
Remifentanil Ce target can range from 0 to 10 ng.ml-1. Remifentanil target is adapted in order to maintain Analgesia Nociception Index (MDMS, Loos, France) in the [50-70] range.
PropofolDrug
propofol is used for induction and maintenance of general anesthesia using Schnider pK/pD model. Propofol Ce target is adapted in order to maintain BiSpectral Index in [40-60] range
ANI monitorDevice
Also called PhysioDoloris (MDMS, Loos, France)
ANI (Analgesia Nociception Index) value is used in the "std_practice" arm for guidance of the remifentanil Ce target
| Study group | Role | What they receive |
|---|---|---|
| ANI-loop | Experimental | arm 1 : remifentanil is automatically administered by a medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index (MDMS, Loos, France) Receives: Device: ANI-REMI-loop; Drug: Remifentanil; Drug: Propofol |
| std_practice | Active comparator | arm 2: remifentanil is administered by a target control device using Minto's remifentanil pK/pD model. This is standard practice for this type of surgery at the Burn Center of the University Hospital of Lille, France. Receives: Device: remifentanil pK/pD target administration device; Drug: Remifentanil; Drug: Propofol; Device: ANI monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
normalized remifentanil administration
ratio of total amount of administered remifentanil with body weight and duration of administration
Measured: During the surgery, an average Three hours and a half
Secondary outcomes (13)
hemodynamic reactivity or bradycardia or hypotension
relative amount of time during which heart rate or SBP exceed 120% of baseline, or heart rate drops below 40/min, or SBP drops below 75 mmHg.
Measured: During the surgery, an average Three hours and a half
total administered ephedrine
total amount of ephedrine administered during general anesthesia
Measured: duration of general anesthesia
Analgesia Nociception Index (ANI)
relative amount of time spent with ANIi in the [0-50], [50-70] and [70-100] windows. Same with ANIm
Measured: During the surgery, an average Three hours and a half
Bispectral Index (BIS)
relative amount of time spent with BIS in the [0-40], [40-60] and [60-100] windows.
Measured: During the surgery, an average Three hours and a half
Change antinociception/nociception balance status
composite measure: heart rate, blood pressure, ANIi, ANIm, end-tidal CO2, PeakPressure
Measured: 5 min before start of nociception, 5 min after start of nociception and 20 min after start of nociception
Pain in PACU
Visual Analog Scale every 15 min in PACU The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme (0, 10).
Measured: During the first two postoperative hours
morphine in PACU
Total amount of administered morphine during PACU stay
Measured: During the first two postoperative hours
ketamine in PACU
Total amount of administered ketamine during PACU stay
Measured: During the first two postoperative hours
nausea/vomiting in PACU
reported number of nausea/vomiting during PACU stay
Measured: During the first two postoperative hours
remi target changes
total number of target changes during general anesthesia
Measured: During the surgery, an average Three hours and a half
propofol target changes
total number of target changes during general anesthesia
Measured: During the surgery, an average Three hours and a half
normalized propofol administration
ratio of total amount of propofol administered with body weight and duration of general anesthesia
Measured: During the surgery, an average Three hours and a half
ANI-REMI-loop switch to manual
number of interventions on ANI-REMI-loop device: switch to manual
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 posted14 Jun 2018
- Study start27 Jun 2018
- Primary completion14 Jun 2022
- Study completion22 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nociceptive PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric prospective randomized controlled clinical trial * arm 1: medical device automatically administering remifentanil, guided by expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index (MDMS, Loos, France) * arm 2 : standard practice : remifentanil is administered using a target controlled device using a pK/pD model of Minto
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu JEANNE, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556696
- Sponsor's protocol ID
- 2016_48
- Other IDs
- 2017-A00858-45
- Acronym
- ANI-LOOP
- Status last verified
- Nov 2022
- First submitted
- 10 Apr 2018
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Jonckheere J, Jeanne M, Keribedj A, Delecroix M, Logier R. Closed-loop administration of analgesic drugs based on heart rate variability analysis. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:506-509. doi: 10.1109/EMBC.2018.8512330.
PubMed 30440445
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Remifentanil Administration Guided by the Analgesia Nociception Index During Propofol Anesthesia
- ClinicalTrials.gov ID
- NCT03556696
- Acronym / sponsor ID
- ANI-LOOP / 2016_48
- Conditions
- Nociceptive Pain, Surgical Procedure, Unspecified
- Keywords
- general anesthesia, analgesia/nociception balance monitoring, expert system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 27 Jun 2018 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 14 Jun 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.
Prospective Randomized Monocentric Clinical Trial during propofol anesthesia. The aim of the study is to test whether the use of a medical device designed to automatically administer remifentanil during surgery based on expert rules and continuous reading of heart rate, blood pressure and the Analgesia Nociception Index results in lower overall remifentanil administration versus standard practice.
Detailed description
Prospective Randomized Monocentric Clinical Trial during propofol anesthesia.
- inclusion: ASA 1, 2 or 3 adult patients scheduled to undergo burn wound surgery in a Burn Center (University Hospital of Lille, France)
- arm 1 : Remifentanil will be automatically administered by an expert system guided by heart rate, blood pressure and the Analgesia Nociception Index (ANI).
- arm 2 : Remifentanil will be administered by a target controlled device using the Minto pK/pD model.
- propofol is administered throughout the procedure with a target controlled device using the pK/pD model of Schnider. The target will be guided by the BiSpectral index values.
- primary endpoint : overall normalized remifentanil administration.
- secondary endpoints : relative amount of time spent in a state of hemodynamic reactivity ; relative amount of time the ANI spends in the [0-50], [50-70] and [70-100] windows ; relative amount of time the BIS spends in the [0-40], [40-60] and [60-100] ; hemodynamic status at various times during anesthesia ; total amount of target modifications of remifentanil and propofol ; total amount of morphine administered in PACU ; total amount of ketamine administered in PACU ; incidence of nausea/vomiting in PACU ;
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Monocentric prospective randomized controlled clinical trial * arm 1: medical device automatically administering remifentanil, guided by expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index (MDMS, Loos, France) * arm 2 : standard practice : remifentanil is administered using a target controlled device using a pK/pD model of Minto
| Arm | Type | Receives |
|---|---|---|
| ANI-loop | Experimental | Device: ANI-REMI-loop, Drug: Remifentanil, Drug: Propofolarm 1 : remifentanil is automatically administered by a medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index (MDMS, Loos, France) |
| std_practice | Active comparator | Device: remifentanil pK/pD target administration device, Drug: Remifentanil, Drug: Propofol, Device: ANI monitorarm 2: remifentanil is administered by a target control device using Minto's remifentanil pK/pD model. This is standard practice for this type of surgery at the Burn Center of the University Hospital of Lille, France. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA 1, 2 or 3 adult patients scheduled to undergo burn wound surgery at the Burn Center of the University Hospital of Lille
Key exclusion criteria (6 listed)
- BMI outside [17 - 35 kg/m2]
- pregnancy or breast feeding women
- non sinus cardiac rhythm
- documented dysautonomia
- complicated diabetes mellitus
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-REMI-loopexperimental medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index for automatic remifentanil administration | Device | ANI-loop |
| remifentanil pK/pD target administration devicestandard practice, remifentanil administration using Minto's pK/pD model | Device | std_practice |
| RemifentanilRemifentanil Ce target can range from 0 to 10 ng.ml-1. Remifentanil target is adapted in order to maintain Analgesia Nociception Index (MDMS, Loos, France) in the [50-70] range. | Drug | ANI-loop, std_practice |
| Propofolpropofol is used for induction and maintenance of general anesthesia using Schnider pK/pD model. Propofol Ce target is adapted in order to maintain BiSpectral Index in [40-60] range | Drug | ANI-loop, std_practice |
| ANI monitorAlso: PhysioDoloris (MDMS, Loos, France)ANI (Analgesia Nociception Index) value is used in the "std_practice" arm for guidance of the remifentanil Ce target | Device | std_practice |
Primary outcome
normalized remifentanil administration
Time frame: During the surgery, an average Three hours and a half
ratio of total amount of administered remifentanil with body weight and duration of administration
13 secondary outcomes
hemodynamic reactivity or bradycardia or hypotension
Time frame: During the surgery, an average Three hours and a half
total administered ephedrine
Time frame: duration of general anesthesia
Analgesia Nociception Index (ANI)
Time frame: During the surgery, an average Three hours and a half
Bispectral Index (BIS)
Time frame: During the surgery, an average Three hours and a half
Change antinociception/nociception balance status
Time frame: 5 min before start of nociception, 5 min after start of nociception and 20 min after start of nociception
Pain in PACU
Time frame: During the first two postoperative hours
morphine in PACU
Time frame: During the first two postoperative hours
ketamine in PACU
Time frame: During the first two postoperative hours
nausea/vomiting in PACU
Time frame: During the first two postoperative hours
remi target changes
Time frame: During the surgery, an average Three hours and a half
propofol target changes
Time frame: During the surgery, an average Three hours and a half
normalized propofol administration
Time frame: During the surgery, an average Three hours and a half
ANI-REMI-loop switch to manual
Time frame: During the surgery, an average Three hours and a half
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 20 Feb 2026.
- Results publication: PubMed 30440445De Jonckheere J, Jeanne M, Keribedj A, Delecroix M, Logier R. Closed-loop administration of analgesic drugs based on heart rate variability analysis. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:506-509. doi: 10.1109/EMBC.2018.8512330.
Related trials for Nociceptive Pain
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Knee Osteoarthritis
Not yet recruitingObservational study
Evaluation of Consciousness Depth (qCON) and Analgesia Depth (qNOX) Indices in General Anesthesia
Cesarean Section (MeSH: D002585), Anesthesia
RecruitingObservational study
Overlapping Pain Trajectory Study
Migraine, Musculoskeletal Pain
Not yet recruiting
TAP vs. ESP Blocks for Post-Cesarean Analgesia
Postoperative Pain After Cesarean Section
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.
Mathieu JEANNE, 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-REMI-loop, remifentanil pK/pD target administration device and Remifentanil 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 1 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 20 Feb 2026. 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?
normalized remifentanil administration (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?
On the ClinicalTrials.gov record for NCT03556696, which also lists 1 linked publication.
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 20 Feb 2026.