Abdominal SurgeryEu-MultiNOLNCT04402242
Impact of NOL Index Intraoperative Guided Remifentanil Analgesia
A study testing Bispectral index and Bispectral index + NOL index in people with Abdominal Surgery, run by Hopital Foch at 3 sites in France.
Trial summary
The Physiological Monitoring Device (PMD-200™) system is comprised of a monitor and a designated finger probe containing 4 sensors. The sensors included are Photoplethysmography (PPG), Galvanic Skin Response (GSR), Accelerometer for movement (ACC) and Thermistor for peripheral temperature (TMP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Surgery
- What is being tested?
- Bispectral index and Bispectral index + NOL index
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 3 sitesFrance
- Study dates
- 13 Apr 2021to 10 Jul 2023
- 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
- Age ≥ 18 years old
- American Society of Anesthesiologists score (ASA) I, II or III stable
- Laparotomy or laparoscopy for major, planned, digestive, urological or gynecological surgery under total intravenous anesthesia (expected total duration > 90 minutes)
- Having sign an informed consent form prior to any study specific procedure
- Being covered by a national health insurance
- Non-Inclusion Criteria:
Show all 15Show fewer
- Pregnancy/lactation
- Patient with antiarrhythmic agents
- Patient with Central nervous system disorder
- Patient with veinous approach difficulties
- Patient at risk of difficult mask ventilation or difficult intubation
- Concomitant use of any type of anesthesia other than general anesthesia (epidural anesthesia, spinal anesthesia, wall block, pericatricial infiltration). Wall blocks and pericatricial infiltrations are allowed if they are carried out at the end of the intervention
- Allergy or intolerance to any of the study drugs
- Patient not understanding French language
- Being deprived of liberty or under guardianship
Who cannot join
- Patient requiring the administration of succinylcholine
- Patient with hemodynamic abnormality just before induction of anesthesia (mean arterial pressure < 65 mm Hg or > 110 mm Hg, heart rate < 45/min or > 90/min
- Concomitant use of any type of anesthesia other than general anesthesia (epidural anesthesia, spinal anesthesia, wall block, pericatricial infiltration). Wall blocks and pericatricial infiltrations are allowed if they are carried out at the end of the intervention
- Concomitant use of IV lidocaine or continuous ketamine (IV, SE) during anaesthesia
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hopital d'Instruction des Armées de Bégin
Saint-Mandé, Saint Mandé, 94160
Foch Hospital
Suresnes, France, 92150
Hôpital d'Instruction des Armées - Sainte-Anne
Toulon, Provence-Alpes-Côte d'Azur Region, 83800
About this study
Official title: Impact of Nociceptive-Level (NOL) Intraoperative Guided Remifentanil Analgesia Versus Standard Clinical Care (SCC) for Elective Major Abdominal Surgery
The Physiological Monitoring Device (PMD-200™) system is comprised of a monitor and a designated finger probe containing 4 sensors. The sensors included are Photoplethysmography (PPG), Galvanic Skin Response (GSR), Accelerometer for movement (ACC) and Thermistor for peripheral temperature (TMP).
The PMD-200 is intended to be used for assessing the nociception level in anesthetized patients.
The purpose of the study is confirmation of a reduction in the dosage of remifentanil allowed by the monitoring of nociception by the NOL which could open the way to a double control of the administration of anesthetic agents: control of the administration of hypnotics by the bispectral index (BIS) and control of the administration of opiate by the NOL.
Read the detailed description
The PMD-200 continuous pain monitor is intended to be used for assessing changes in pain levels. The system monitors the physiological responses to pain using a relative pain index from 0-100, called the Nociception Level (NOL®) index. In the NOL index, 0 represents no nociception or pain and 100 represents high nociception or pain level.
The PMD-200 system consists of a monitor and a specific finger probe containing 4 sensors. The sensors included are Photoplethysmography (PPG), Galvanic Skin Response (GSR), Accelerometer for movement (ACC) and Thermistor for peripheral temperature (TMP).
The PMD-200™ is intended to be used for assessing the nociception level in anesthetized patients. The device is European Conformity (CE) marked and commercially available.
Meier et al. recently published a randomized trial involving 80 patients for major abdominal surgery, one group receiving routine care and the other NOL-guided analgesia. In the latter group, the remifentanil concentration was reduced when NOL values were below 10 or increased when NOL values were above 25 for at least 1 minute. In both groups, propofol was titrated to have bispectral index values between 45 and 55. Remifentanil administration was reduced in the NOL-guided group: 0.119 ± 0.033 vs 0.086 ± 0.032 μg.kg.min (p < 0.001). In the NOL- guided group, 2 out of 40 (5%) patients had hypotension (mean blood pressure less than 55 mm Hg) compared to 11 out of 40 (28%) in the control group (p = 0.006) and 16 out of 40 (40%) patients received vasoactive drugs vs 25 out of 40 (63%) (p = 0.044).
Previous results cover a small number of patients treated in a single center. The purpose of this study is to confirm this result within a multicenter study involving a larger group of patients. Confirmation of a reduction in the dosage of remifentanil allowed by the monitoring of nociception by the NOL will open the way to a double control of the administration of anesthetic agents: control of the administration of hypnotics by the bispectral index (BIS) and control of the administration of opiate by the NOL.
- Conditions
- Abdominal Surgery
- Being tested
- Bispectral index, Bispectral index + NOL index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispectral indexDevice
Anesthesia monitoring
Bispectral index + NOL indexDevice
Anesthesia monitoring
| Study group | Role | What they receive |
|---|---|---|
| "SCS" Group | Sham comparator | Receiving anesthesia according to routine standard care, with the use of the "hidden" NOL (used to compare the data at the end of anesthesia with those of the classic BIS - without monitoring of the anesthesia by the NOL (without adjustment of treatments )) Receives: Device: Bispectral index |
| NOL Group | Experimental | Receiving anesthesia monitored by the NOL Receives: Device: Bispectral index + NOL index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remifentanil consumption during maintenance
Remifentanil consumption during anesthesia maintenance in μg/kg/min
Measured: surgery day (D0)
Secondary outcomes (9)
Remifentanil consumption during induction
Remifentanil consumption during anesthesia induction in μg/kg/min
Measured: surgery day (D0)
Propofol consumption during induction
Propofol consumption during anesthesia induction in μg/kg/min
Measured: surgery day (D0)
Propofol consumption during maintenance
Propofol consumption during anesthesia maintenance in μg/kg/min
Measured: surgery day (D0)
Proportion of patients with intraoperative hemodynamic abnormality in the NOL index group compared to standard care group during induction
A hemodynamic abnormality is defined as:
- administration of a vasoactive agent (ephedrine, phenylephrine, norepinephrine, adrenaline, atropine)
- and/or average blood pressure < 55 mmHg or < 60 mmHg or < 65 mmHg for any length of time
- an/or a systolic blood pressure > 140 mmHg for any length of time
- and/or a heart rate < 45 or > 90 /min
Measured: surgery day (D0)
Proportion of patients with intraoperative hemodynamic abnormality in the NOL index group compared to standard care group during maintenance
Mean Blood pressure events during anesthesia inductio A hemodynamic abnormality is defined as:
- administration of a vasoactive agent (ephedrine, phenylephrine, norepinephrine, adrenaline, atropine)
- and/or average blood pressure < 55 mmHg or < 60 mmHg or < 65 mmHg for any length of time
- an/or a systolic blood pressure > 140 mmHg for any length of time
- and/or a heart rate < 45 or > 90 /min
Measured: surgery day (D0)
Proportion of patients with intraoperative anesthetic abnormality in the NOL index group compared to standard care group during induction
An anesthetic abnormality is defined as:
- a bispectral (BIS) index < 40 or > 60 for at least one minute
- and/or a Burst Suppression Ratio (BSR) index > 10% during one minute
- and/or a NOL index > 25 or < 10 for at least 2 minutes
Measured: surgery day (D0)
Proportion of patients with intraoperative anesthetic abnormality in the NOL index group compared to standard care group during maintenance
An anesthetic abnormality is defined as:
- a bispectral (BIS) index < 40 or > 60 for at least one minute
- and/or a Burst Suppression Ratio (BSR) index > 10% during one minute
- and/or a NOL index > 25 or < 10 for at least 2 minutes
Measured: surgery day (D0)
Wake up time
delay between the end of Propofol or Sugammadex/Neostigmine and extubation
Measured: surgery day (D0)
Intensity of pain in PACU (post-anesthesia care unit)
Morphine consumption in PACU (post-anesthesia care unit)
Measured: surgery day (D0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start13 Apr 2021
- Primary completion10 Jul 2023
- Study completion10 Jul 2023
Why it stopped: The very slow pace of enrolment and the difficulty in identifying a third study centre.
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 Abdominal SurgeryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, multi-center, single blinded interventional study with 2 parallel groups: standard clinical care (SCC group, control group) and NOL-guided analgesia (NOL guided analgesia group, interventional group), stratified by site
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgan LE GUEN, MD, Principal investigator, Foch HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402242
- Sponsor's protocol ID
- 2019_0051
- Acronym
- Eu-MultiNOL
- Status last verified
- Jun 2026
- First submitted
- 20 Apr 2020
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meijer FS, Martini CH, Broens S, Boon M, Niesters M, Aarts L, Olofsen E, van Velzen M, Dahan A. Nociception-guided versus Standard Care during Remifentanil-Propofol Anesthesia: A Randomized Controlled Trial. Anesthesiology. 2019 May;130(5):745-755. doi: 10.1097/ALN.0000000000002634.
PubMed 30829658
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nociceptive-Level (NOL) Intraoperative Guided Remifentanil Analgesia Versus Standard Clinical Care (SCC) for Elective Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04402242
- Acronym / sponsor ID
- Eu-MultiNOL / 2019_0051
- Conditions
- Abdominal Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The very slow pace of enrolment and the difficulty in identifying a third study centre.
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 10 Jul 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 26 May 2020 (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 Physiological Monitoring Device (PMD-200™) system is comprised of a monitor and a designated finger probe containing 4 sensors. The sensors included are Photoplethysmography (PPG), Galvanic Skin Response (GSR), Accelerometer for movement (ACC) and Thermistor for peripheral temperature (TMP).
The PMD-200 is intended to be used for assessing the nociception level in anesthetized patients.
The purpose of the study is confirmation of a reduction in the dosage of remifentanil allowed by the monitoring of nociception by the NOL which could open the way to a double control of the administration of anesthetic agents: control of the administration of hypnotics by the bispectral index (BIS) and control of the administration of opiate by the NOL.
Detailed description
The PMD-200 continuous pain monitor is intended to be used for assessing changes in pain levels. The system monitors the physiological responses to pain using a relative pain index from 0-100, called the Nociception Level (NOL®) index. In the NOL index, 0 represents no nociception or pain and 100 represents high nociception or pain level.
The PMD-200 system consists of a monitor and a specific finger probe containing 4 sensors. The sensors included are Photoplethysmography (PPG), Galvanic Skin Response (GSR), Accelerometer for movement (ACC) and Thermistor for peripheral temperature (TMP).
The PMD-200™ is intended to be used for assessing the nociception level in anesthetized patients. The device is European Conformity (CE) marked and commercially available.
Meier et al. recently published a randomized trial involving 80 patients for major abdominal surgery, one group receiving routine care and the other NOL-guided analgesia. In the latter group, the remifentanil concentration was reduced when NOL values were below 10 or increased when NOL values were above 25 for at least 1 minute. In both groups, propofol was titrated to have bispectral index values between 45 and 55. Remifentanil administration was reduced in the NOL-guided group: 0.119 ± 0.033 vs 0.086 ± 0.032 μg.kg.min (p < 0.001). In the NOL- guided group, 2 out of 40 (5%) patients had hypotension (mean blood pressure less than 55 mm Hg) compared to 11 out of 40 (28%) in the control group (p = 0.006) and 16 out of 40 (40%) patients received vasoactive drugs vs 25 out of 40 (63%) (p = 0.044).
Previous results cover a small number of patients treated in a single center. The purpose of this study is to confirm this result within a multicenter study involving a larger group of patients. Confirmation of a reduction in the dosage of remifentanil allowed by the monitoring of nociception by the NOL will open the way to a double control of the administration of anesthetic agents: control of the administration of hypnotics by the bispectral index (BIS) and control of the administration of opiate by the NOL.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, multi-center, single blinded interventional study with 2 parallel groups: standard clinical care (SCC group, control group) and NOL-guided analgesia (NOL guided analgesia group, interventional group), stratified by site
| Arm | Type | Receives |
|---|---|---|
| "SCS" Group | Sham comparator | Device: Bispectral indexReceiving anesthesia according to routine standard care, with the use of the "hidden" NOL (used to compare the data at the end of anesthesia with those of the classic BIS - without monitoring of the anesthesia by the NOL (without adjustment of treatments )) |
| NOL Group | Experimental | Device: Bispectral index + NOL indexReceiving anesthesia monitored by the NOL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18 years old
- American Society of Anesthesiologists score (ASA) I, II or III stable
- Laparotomy or laparoscopy for major, planned, digestive, urological or gynecological surgery under total intravenous anesthesia (expected total duration > 90 minutes)
- Having sign an informed consent form prior to any study specific procedure
- Being covered by a national health insurance
Key exclusion criteria (4 listed)
- Patient requiring the administration of succinylcholine
- Patient with hemodynamic abnormality just before induction of anesthesia (mean arterial pressure < 65 mm Hg or > 110 mm Hg, heart rate < 45/min or > 90/min
- Concomitant use of any type of anesthesia other than general anesthesia (epidural anesthesia, spinal anesthesia, wall block, pericatricial infiltration). Wall blocks and pericatricial infiltrations are allowed if they are carried out at the end of the intervention
- Concomitant use of IV lidocaine or continuous ketamine (IV, SE) during anaesthesia
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 |
|---|---|---|
| Bispectral indexAnesthesia monitoring | Device | "SCS" Group |
| Bispectral index + NOL indexAnesthesia monitoring | Device | NOL Group |
Primary outcome
Remifentanil consumption during maintenance
Time frame: surgery day (D0)
Remifentanil consumption during anesthesia maintenance in μg/kg/min
9 secondary outcomes
Remifentanil consumption during induction
Time frame: surgery day (D0)
Propofol consumption during induction
Time frame: surgery day (D0)
Propofol consumption during maintenance
Time frame: surgery day (D0)
Proportion of patients with intraoperative hemodynamic abnormality in the NOL index group compared to standard care group during induction
Time frame: surgery day (D0)
Proportion of patients with intraoperative hemodynamic abnormality in the NOL index group compared to standard care group during maintenance
Time frame: surgery day (D0)
Proportion of patients with intraoperative anesthetic abnormality in the NOL index group compared to standard care group during induction
Time frame: surgery day (D0)
Proportion of patients with intraoperative anesthetic abnormality in the NOL index group compared to standard care group during maintenance
Time frame: surgery day (D0)
Wake up time
Time frame: surgery day (D0)
Intensity of pain in PACU (post-anesthesia care unit)
Time frame: surgery day (D0)
Results and safety
The study was stopped early (reason given: The very slow pace of enrolment and the difficulty in identifying a third study centre.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Results publication: PubMed 30829658Meijer FS, Martini CH, Broens S, Boon M, Niesters M, Aarts L, Olofsen E, van Velzen M, Dahan A. Nociception-guided versus Standard Care during Remifentanil-Propofol Anesthesia: A Randomized Controlled Trial. Anesthesiology. 2019 May;130(5):745-755. doi: 10.1097/ALN.0000000000002634.
- Individual participant dataSharing planned: No
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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.
Morgan LE GUEN, MD principal investigator
Foch HOSPITAL
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bispectral index and Bispectral index + NOL index in people with Abdominal Surgery, run by Hopital Foch at 3 sites 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 15 inclusion and 4 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: stopped early, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: The very slow pace of enrolment and the difficulty in identifying a third study centre.). Results are not available in the source record.
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?
Remifentanil consumption during maintenance (time frame: surgery day (D0)). 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 NCT04402242, 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 11 Jun 2026.