General AnesthesiaAIVOC-ANINCT01893723
Analgesia Nociception Index Guided Remifentanil Administration During Propofol Anesthesia for Laparoscopic Surgery
A study testing ANI guided remifentanil and ANI blind arm in people with General Anesthesia, run by University Hospital, Lille at 5 sites in 2 countries.
Trial summary
The Physiodoloris (MetroDoloris, Lille, France) monitor, CE marqued, uses the ECG signal in order to compute the Analgesia Nociception Index (ANI) which has been shown to measure the relative parasympathetic tone, and hence to reflect the analgesia/nociception balance during general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Anesthesia
- What is being tested?
- ANI guided remifentanil and ANI blind arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jun 2012to May 2015
- 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
- laparoscopic cholecystectomy or gynecological laparoscopic surgery
- ASA I or II
- adult patient
- body mass index between 17 and 33 kg/m2
Who cannot join
- pregnancy
- arrhythmia
- pace maker
- diabetes mellitus
- dysautonomia
- treatment with beta blocking agents
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
France4 sites
Clinique privée d'ANTONY
Antony, 92160
University Hospital Claude Huriez
Lille, 59000
University Hospital Roger Salengro
Lille, 59000
University Hospital
Saint-Etienne, 42270
About this study
Official title: Analgesia Nociception Index Guided Remifentanil Administration During Propofol Anesthesia for Laparoscopic Surgery : Multicenter Randomized Clinical Trial
The Physiodoloris (MetroDoloris, Lille, France) monitor, CE marqued, uses the ECG signal in order to compute the Analgesia Nociception Index (ANI) which has been shown to measure the relative parasympathetic tone, and hence to reflect the analgesia/nociception balance during general anesthesia. The primary endpoint of this randomized multicenter study is to measure whether there is a benefit to use the ANI in order to adapt remifentanil administration during propofol anesthesia for laparoscopic surgery. Primary endpoint : lesser proportion of patients presenting with at least one episode of hemodynamic reactivity, hypotension or bradycardia in the ANI guided group vs control group ?
Read the detailed description
The Physiodoloris (MetroDoloris, Lille, France) monitor, CE marqued, uses the ECG signal in order to compute the Analgesia Nociception Index (ANI) which has been shown to measure the relative parasympathetic tone, and hence to reflect the analgesia/nociception balance during general anesthesia. The primary endpoint of this randomized multicenter study is to measure whether there is a benefit to use the ANI in order to adapt remifentanil administration during propofol anesthesia for laparoscopic surgery. Primary endpoint is: lesser proportion of patients presenting with at least one episode of hemodynamic reactivity, hypotension or bradycardia in the ANI guided group vs control group ?
- Conditions
- General Anesthesia
- Being tested
- ANI guided remifentanil, ANI blind arm
- Keywords
- autonomous nervous system monitoring, analgesia nociception balance, remifentanil, analgesia nociception index, hemodynamic reactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANI guided remifentanilProcedure or surgery
remifentanil administration during propofol anesthesia for laparoscopic surgery is ANI guided
ANI blind armProcedure or surgery
remifentanil administration during propofol anesthesia for laparoscopic surgery is not ANI guided
| Study group | Role | What they receive |
|---|---|---|
| ANI guided remifentanil arm | Experimental | remifentanil targets are increased or decreased depending on ANI readings. In case of high blood pressure associated with elevated ANI, nicardipine is administered. Receives: Procedure: ANI guided remifentanil |
| ANI blind arm | Other | remifentanil target is adapted as is usual during general anesthesia, depending on hemodynamic reactions to nociceptive surgical stimulations. In case of elevated blood pressure despite a maximum target of 10 ng/ml (Minto Pk/pD model), then nicardipine is administered. Receives: Procedure: ANI blind arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients presenting at least once with hemodynamic reactivity, hypotension or bradycardia
Measured: end of surgery (around 60 to 90 min after start)
Secondary outcomes (7)
total administered remifentanil
Measured: end of surgery
number of target changes
Measured: end of surgery (around 60 to 90 min after start)
morphine sulfate total administration after end of surgery
Measured: during two hours after end of surgery
Visual Analog Scale evaluation of pain after surgery
Measured: during two hours after end of surgery
ANI measure during surgery
Measured: from start to end of surgery (around 60 to 90 min)
number of bradycardia and hypotension
Measured: from start to end of surgery (around 60 to 90 min )
total administered dose of ephedrine
Measured: between start and end of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startJun 2012
- Primary completionMay 2014
- Study completionMay 2015
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 General AnesthesiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu JEANNE, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893723
- Sponsor's protocol ID
- 2010_51
- Other IDs
- 2011-A00947-34
- Acronym
- AIVOC-ANI
- Status last verified
- Apr 2026
- First submitted
- 18 Jun 2013
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Logier R, De Jonckheere J, Dassonneville A, Jeanne M. Comparison of pulse rate variability and heart rate variability for high frequency content estimation. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:936-939. doi: 10.1109/EMBC.2016.7590855.
PubMed 28268478
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia Nociception Index Guided Remifentanil Administration During Propofol Anesthesia for Laparoscopic Surgery : Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01893723
- Acronym / sponsor ID
- AIVOC-ANI / 2010_51
- Conditions
- General Anesthesia
- Keywords
- autonomous nervous system monitoring, analgesia nociception balance, remifentanil, analgesia nociception index, hemodynamic reactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 Jul 2013 (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 Physiodoloris (MetroDoloris, Lille, France) monitor, CE marqued, uses the ECG signal in order to compute the Analgesia Nociception Index (ANI) which has been shown to measure the relative parasympathetic tone, and hence to reflect the analgesia/nociception balance during general anesthesia. The primary endpoint of this randomized multicenter study is to measure whether there is a benefit to use the ANI in order to adapt remifentanil administration during propofol anesthesia for laparoscopic surgery. Primary endpoint : lesser proportion of patients presenting with at least one episode of hemodynamic reactivity, hypotension or bradycardia in the ANI guided group vs control group ?
Detailed description
The Physiodoloris (MetroDoloris, Lille, France) monitor, CE marqued, uses the ECG signal in order to compute the Analgesia Nociception Index (ANI) which has been shown to measure the relative parasympathetic tone, and hence to reflect the analgesia/nociception balance during general anesthesia. The primary endpoint of this randomized multicenter study is to measure whether there is a benefit to use the ANI in order to adapt remifentanil administration during propofol anesthesia for laparoscopic surgery. Primary endpoint is: lesser proportion of patients presenting with at least one episode of hemodynamic reactivity, hypotension or bradycardia in the ANI guided group vs control group ?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANI guided remifentanil arm | Experimental | Procedure: ANI guided remifentanilremifentanil targets are increased or decreased depending on ANI readings. In case of high blood pressure associated with elevated ANI, nicardipine is administered. |
| ANI blind arm | Other | Procedure: ANI blind armremifentanil target is adapted as is usual during general anesthesia, depending on hemodynamic reactions to nociceptive surgical stimulations. In case of elevated blood pressure despite a maximum target of 10 ng/ml (Minto Pk/pD model), then nicardipine is administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- laparoscopic cholecystectomy or gynecological laparoscopic surgery
- ASA I or II
- adult patient
- body mass index between 17 and 33 kg/m2
Key exclusion criteria (6 listed)
- pregnancy
- arrhythmia
- pace maker
- diabetes mellitus
- dysautonomia
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 guided remifentanilremifentanil administration during propofol anesthesia for laparoscopic surgery is ANI guided | Procedure or surgery | ANI guided remifentanil arm |
| ANI blind armremifentanil administration during propofol anesthesia for laparoscopic surgery is not ANI guided | Procedure or surgery | ANI blind arm |
Primary outcome
Proportion of patients presenting at least once with hemodynamic reactivity, hypotension or bradycardia
Time frame: end of surgery (around 60 to 90 min after start)
7 secondary outcomes
total administered remifentanil
Time frame: end of surgery
number of target changes
Time frame: end of surgery (around 60 to 90 min after start)
morphine sulfate total administration after end of surgery
Time frame: during two hours after end of surgery
Visual Analog Scale evaluation of pain after surgery
Time frame: during two hours after end of surgery
ANI measure during surgery
Time frame: from start to end of surgery (around 60 to 90 min)
number of bradycardia and hypotension
Time frame: from start to end of surgery (around 60 to 90 min )
total administered dose of ephedrine
Time frame: between start and end of anesthesia
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 21 Apr 2026.
- Results publication: PubMed 28268478Logier R, De Jonckheere J, Dassonneville A, Jeanne M. Comparison of pulse rate variability and heart rate variability for high frequency content estimation. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:936-939. doi: 10.1109/EMBC.2016.7590855.
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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.
Mathieu JEANNE, MD principal investigator
University Hospital, Lille
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANI guided remifentanil and ANI blind arm in people with General Anesthesia, run by University Hospital, Lille at 5 sites in 2 countries.
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 4 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 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, 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?
Proportion of patients presenting at least once with hemodynamic reactivity, hypotension or bradycardia (time frame: end of surgery (around 60 to 90 min after start)). 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 NCT01893723, 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 21 Apr 2026.