AnesthesiaNIPESTIMNCT04381637
Newborn Infant Parasympathetic Evaluation (NIPE) Index After Standardized Tetanic Stimulations Under General Anesthesia
A study testing NIPE monitor and Tetanic stimulations in people with Anesthesia, run by University Hospital, Lille at 1 site in France.
Trial summary
NIPE monitor is the recently developed pediatric version of the ANI monitor, which is used in adults to monitor analgesia during general anesthesia. In adults, under general anesthesia, ANI decreases after a nociceptive stimulation. The amplitude of this decrease is related to the intensity of the stim. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- NIPE monitor and Tetanic stimulations
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jan 2021to 10 Jun 2021
- 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Elective surgery under general anesthesia requiring tracheal intubation and muscle relaxation
- Written informed consent obtained from parents (and from child if appropriate)
Who cannot join
- Thoracic or cardiac surgery
- Cardiac arrhythmia, Pace maker
- Analgesic medication less than 24 hours before surgery
- Chronic anticholinergic medication
- Contraindication to muscle relaxants or general anesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Newborn Infant Parasympathetic Evaluation (NIPE) Index After Three Standardized Tetanic Stimulations (10, 30 and 60 Miliamps) Performed in a Randomized Sequence Under General Anesthesia in a Pediatric Population
NIPE monitor is the recently developed pediatric version of the ANI monitor, which is used in adults to monitor analgesia during general anesthesia. In adults, under general anesthesia, ANI decreases after a nociceptive stimulation. The amplitude of this decrease is related to the intensity of the stim. This study aims to investigate if NIPE index decreases in the same manner after stimulations in anesthetized children.
- Conditions
- Anesthesia
- Being tested
- NIPE monitor, Tetanic stimulations
- Keywords
- Monitoring, General anesthesia, Analgesia, Pain, Pediatric
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIPE monitorDevice
NIPE monitor connected to the anesthetic station. No part of the device in contact with the patient. No action on patient or anesthesia. Automatic recording of Heart rate and NIPE index during the study period.
Tetanic stimulationsProcedure or surgery
Three tetanic stimulations will be performed (10-30 and 60 milliamps) under general anesthesia, before surgical incision.
Stims performed via the muscle relaxation monitor (used in standard practice in this population) Each stim lasts for 5 seconds. Interval between two stims : 3-5 minutes Order on intensities randomized by a latin square of order 3.
| Study group | Role | What they receive |
|---|---|---|
| NIPE | Experimental | Not described Receives: Device: NIPE monitor; Procedure: Tetanic stimulations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of NIPE index (∆NIPE)
∆NIPE = [NIPE minimal value in the 3 minutes following the stim] - [NIPE before stim]
NIPE varies from 0 to 100. Monitor displays one value per second. NIPE index expected to decrease after stim.
Measured: 3 minutes following tetanic stimulation
Secondary outcomes (1)
Heart rate Variation (∆HR)
∆HR = [HR maximal value in the 3 minutes following the stim] - [HR before stim] Heart rate expected to increase after stim.
Measured: 3 minutes following tetanic stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start28 Jan 2021
- Primary completion10 Jun 2021
- Study completion10 Jun 2021
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
- The research does not involve the evaluation or comparison of medical strategies.The order of application of the stimuli will be randomized according to a Latin square of order 3.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Apicil
- Responsible party
- Sponsor
- Investigators
- Anne LAFFARGUE, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381637
- Sponsor's protocol ID
- 2019_32
- Other IDs
- 2020-A00295-34
- Acronym
- NIPESTIM
- Status last verified
- Jan 2023
- First submitted
- 6 May 2020
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lebrun S, Boccara J, Cailliau E, Herbet M, Tavernier B, Constant I, Sabourdin N. Quantitative assessment of a pediatric nociception monitor in children under sevoflurane anesthesia. Reg Anesth Pain Med. 2022 Jun 2:rapm-2022-103547. doi: 10.1136/rapm-2022-103547. Online ahead of print.
PubMed 35654480
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Newborn Infant Parasympathetic Evaluation (NIPE) Index After Three Standardized Tetanic Stimulations (10, 30 and 60 Miliamps) Performed in a Randomized Sequence Under General Anesthesia in a Pediatric Population
- ClinicalTrials.gov ID
- NCT04381637
- Acronym / sponsor ID
- NIPESTIM / 2019_32
- Conditions
- Anesthesia
- Keywords
- Monitoring, General anesthesia, Analgesia, Pain, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Fondation Apicil
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 11 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.
NIPE monitor is the recently developed pediatric version of the ANI monitor, which is used in adults to monitor analgesia during general anesthesia. In adults, under general anesthesia, ANI decreases after a nociceptive stimulation. The amplitude of this decrease is related to the intensity of the stim. This study aims to investigate if NIPE index decreases in the same manner after stimulations in anesthetized children.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The research does not involve the evaluation or comparison of medical strategies.The order of application of the stimuli will be randomized according to a Latin square of order 3.
| Arm | Type | Receives |
|---|---|---|
| NIPE | Experimental | Device: NIPE monitor, Procedure: Tetanic stimulations |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Elective surgery under general anesthesia requiring tracheal intubation and muscle relaxation
- Written informed consent obtained from parents (and from child if appropriate)
Key exclusion criteria (5 listed)
- Thoracic or cardiac surgery
- Cardiac arrhythmia, Pace maker
- Analgesic medication less than 24 hours before surgery
- Chronic anticholinergic medication
- Contraindication to muscle relaxants or general anesthetics
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 |
|---|---|---|
| NIPE monitorNIPE monitor connected to the anesthetic station. No part of the device in contact with the patient. No action on patient or anesthesia. Automatic recording of Heart rate and NIPE index during the study period. | Device | NIPE |
| Tetanic stimulationsThree tetanic stimulations will be performed (10-30 and 60 milliamps) under general anesthesia, before surgical incision. Stims performed via the muscle relaxation monitor (used in standard practice in this population) Each stim lasts for 5 seconds. Interval between two stims : 3-5 minutes Order on intensities randomized by a latin square of order 3. | Procedure or surgery | NIPE |
Primary outcome
Variation of NIPE index (∆NIPE)
Time frame: 3 minutes following tetanic stimulation
∆NIPE = [NIPE minimal value in the 3 minutes following the stim] - [NIPE before stim] NIPE varies from 0 to 100. Monitor displays one value per second. NIPE index expected to decrease after stim.
1 secondary outcome
Heart rate Variation (∆HR)
Time frame: 3 minutes following tetanic 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 Jan 2023.
- Derived from this study: PubMed 35654480Lebrun S, Boccara J, Cailliau E, Herbet M, Tavernier B, Constant I, Sabourdin N. Quantitative assessment of a pediatric nociception monitor in children under sevoflurane anesthesia. Reg Anesth Pain Med. 2022 Jun 2:rapm-2022-103547. doi: 10.1136/rapm-2022-103547. Online ahead of print.
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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.
Anne LAFFARGUE, MD 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 NIPE monitor and Tetanic stimulations in people with Anesthesia, 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 5 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 Jan 2023. 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?
Variation of NIPE index (∆NIPE) (time frame: 3 minutes following tetanic 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 NCT04381637, 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 Jan 2023.