AnesthesiaSTIMNOLNCT05233449
NoL Index Response to Stimulation in Anesthetized Children
A study testing NoL monitor and Stimulation in people with Anesthesia, run by University Hospital, Lille at 2 sites in France.
Trial summary
The Nociception Level (NoL) is an index obtained via a non-invasive monitor, that is currently used to assess nociception in anesthetized adults. The NoL index varies from 0 to 100. It increases in response to nociceptive stimuli. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- NoL monitor and Stimulation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 4 Mar 2022to 17 May 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 5-12 years
- Elective surgery under general anesthesia
- Written informed consent
Who cannot join
- Cardiac surgery
- Opioid intake < 24 hours before surgery
- Cardiac arrhythmia
- Pace maker
- Pheochromocytoma
- Anti-arrhythmic medication
Show all 9Show fewer
- Anticholinergic medication
- Raynaud syndrome
- Digital anomaly (malformative, traumatic)
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hopital Roger Salengro, CHU Lille
Lille
Hu Est Parisien Site Trousseau Aphp
Paris
About this study
Official title: Nociception Level Index (NoL) Variation After Standardized Stimulation Under General Anesthesia in Children
The Nociception Level (NoL) is an index obtained via a non-invasive monitor, that is currently used to assess nociception in anesthetized adults. The NoL index varies from 0 to 100. It increases in response to nociceptive stimuli. The objective of this study was to investigate if the NoL index also indicates the level of nociception in anesthetized children. In children anesthetized according to standard practice, before surgical incision, three 5-seconds stimulations will be performed with different intensities (10, 30 and 60 milliamps). The order of the stimulations intensities will be randomized. The hypothesis of study is that the intensity of stimulation will influence the magnitude of NoL-index increase in response to the stimulation.
- Conditions
- Anesthesia
- Being tested
- NoL monitor, Stimulation
- Keywords
- General anesthesia, Nociception, Monitoring, Nociception level, NoL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NoL monitorDevice
NoL monitor : non invasive, adhesive digital device
StimulationProcedure or surgery
Stimulation : 100 Hertz, 5 seconds, 10-30-60 milliamps, inner forearm
| Study group | Role | What they receive |
|---|---|---|
| Children anesthetized | Experimental | Inhalatory general anesthesia with sevoflurane 0.9 Minimal Alveolar Concentration and alfentanil 10 µg/kg Receives: Device: NoL monitor; Procedure: Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
NoL variation = [(Maximal NoL value in the 5 minutes following the stimulation) - (NoL before stimulation)] / [NoL before stimulation]
NoL variation = [(Maximal NoL value in the 5 minutes following the stimulation) - (NoL before stimulation)] / [NoL before stimulation]
Measured: 5 minutes after stimulation
Secondary outcomes (2)
Systolic Blood Pressure (SBP) variation
SBP variation = [(Maximal SBP value in the 5 minutes following the stimulation) - (SBP before stimulation)] / [SBP before stimulation]
Measured: 5 minutes after stimulation
Analgesia Nociception Index (ANI) variation
ANI variation = [(ANI before stimulation - (Minimal ANI value in the 5 minutes following the stimulation)] / [ANI before stimulation]
Measured: 5 minutes after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start4 Mar 2022
- Primary completion17 May 2022
- Study completion17 May 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 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
- Not applicable
- Intervention model
- Single group
- Model description
- In order to avoid the bias related to the order of the stimuli, the order of application of the stimuli will be randomized according to a Latin square of order 3.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nada Sabourdin, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233449
- Sponsor's protocol ID
- 2021_0434
- Other IDs
- 2021-A02797-34
- Acronym
- STIMNOL
- Status last verified
- Dec 2025
- First submitted
- 31 Jan 2022
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chemam S, Cailliau E, Bert D, Tavernier B, Constant I, Sabourdin N. Nociception level response to calibrated stimulations in children: First assessment of the nociception level index in pediatric anesthesia. Anaesth Crit Care Pain Med. 2023 Jun;42(3):101207. doi: 10.1016/j.accpm.2023.101207. Epub 2023 Mar 1.
PubMed 36863410
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nociception Level Index (NoL) Variation After Standardized Stimulation Under General Anesthesia in Children
- ClinicalTrials.gov ID
- NCT05233449
- Acronym / sponsor ID
- STIMNOL / 2021_0434
- Conditions
- Anesthesia
- Keywords
- General anesthesia, Nociception, Monitoring, Nociception level, NoL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 10 Feb 2022 (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 Nociception Level (NoL) is an index obtained via a non-invasive monitor, that is currently used to assess nociception in anesthetized adults. The NoL index varies from 0 to 100. It increases in response to nociceptive stimuli. The objective of this study was to investigate if the NoL index also indicates the level of nociception in anesthetized children. In children anesthetized according to standard practice, before surgical incision, three 5-seconds stimulations will be performed with different intensities (10, 30 and 60 milliamps). The order of the stimulations intensities will be randomized. The hypothesis of study is that the intensity of stimulation will influence the magnitude of NoL-index increase in response to the stimulation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In order to avoid the bias related to the order of the stimuli, the order of application of the stimuli will be randomized according to a Latin square of order 3.
| Arm | Type | Receives |
|---|---|---|
| Children anesthetized | Experimental | Device: NoL monitor, Procedure: StimulationInhalatory general anesthesia with sevoflurane 0.9 Minimal Alveolar Concentration and alfentanil 10 µg/kg |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 5-12 years
- Elective surgery under general anesthesia
- Written informed consent
Key exclusion criteria (9 listed)
- Cardiac surgery
- Opioid intake < 24 hours before surgery
- Cardiac arrhythmia
- Pace maker
- Pheochromocytoma
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 |
|---|---|---|
| NoL monitorNoL monitor : non invasive, adhesive digital device | Device | Children anesthetized |
| StimulationStimulation : 100 Hertz, 5 seconds, 10-30-60 milliamps, inner forearm | Procedure or surgery | Children anesthetized |
Primary outcome
NoL variation = [(Maximal NoL value in the 5 minutes following the stimulation) - (NoL before stimulation)] / [NoL before stimulation]
Time frame: 5 minutes after stimulation
NoL variation = [(Maximal NoL value in the 5 minutes following the stimulation) - (NoL before stimulation)] / [NoL before stimulation]
2 secondary outcomes
Systolic Blood Pressure (SBP) variation
Time frame: 5 minutes after stimulation
Analgesia Nociception Index (ANI) variation
Time frame: 5 minutes after stimulation
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 Dec 2025.
- Results publication: PubMed 36863410Chemam S, Cailliau E, Bert D, Tavernier B, Constant I, Sabourdin N. Nociception level response to calibrated stimulations in children: First assessment of the nociception level index in pediatric anesthesia. Anaesth Crit Care Pain Med. 2023 Jun;42(3):101207. doi: 10.1016/j.accpm.2023.101207. Epub 2023 Mar 1.
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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.
Nada Sabourdin, MD principal investigator
University Hospital, Lille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NoL monitor and Stimulation in people with Anesthesia, run by University Hospital, Lille at 2 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 3 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 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
NoL variation = [(Maximal NoL value in the 5 minutes following the stimulation) - (NoL before stimulation)] / [NoL before stimulation] (time frame: 5 minutes after stimulation). 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 NCT05233449, 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 26 Dec 2025.