Nociceptive PainNOLvsSCANCT05998564
Comparison of the Skin Conductance Algesimeter and the Nociception Level Index in the Paediatric Population. An Observational Study.
An observational study of Nociceptive Pain and Anesthesia, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Evaluation and comparison of the skin conductance algesimeter(SCA) and the nociception level index(NOL) in the paediatric population (1-12 years) during surgery with general anaesthesia with bispectral index(BIS) in a tertiary hospital in The Netherlands. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Nociceptive Pain, Anesthesia, Pain
- What is being tested?
- Connecting patients to both non-invasive monitors to observe and compare the monitor's capabilities.
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Sep 2023to 25 Oct 2024
- Phase
- Observational
- 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: A total of 50 patients. 25 patients aged 1-4 years old, and 25 patients aged 5-12 years old that are scheduled to undergo elective surgery under general anaesthesia. Patients will be enrolled after obtaining written informed consent. We decided to evaluate the SCA and NOL index in two age groups because of the significant differences of maturations of the bodies across different ages that might influence the measurements made by the SCA and NOL monitor. Furthermore the maturation of the brain of a paediatric patient also differs significantly across different ages. Leading to significant differences in EEG patterns and corresponding BIS monitor values across age groups 1-4 and groups 5-11. Therefore, assessing the NOL and SCA in these two difference age groups results in a better ability to assess the homogeneity of the population as we will also be able to quantify and compare the depth of anesthesia through BIS monitor in these two age groups.
Who may be able to join
- Male or female
- ASA I, ASA II and ASA III
- Aged 1 to 12 years old
- Scheduled to undergo elective surgery with general anaesthesia
- Written informed consent obtained from subject or/and subject's legal representatives.
Who cannot join
- Known allergy to the adhesive tape used in the sensors.
- Patients that do not meet the inclusion criteria will be excluded.
- No free available limb to attach the probes to.
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation and comparison of the skin conductance algesimeter(SCA) and the nociception level index(NOL) in the paediatric population (1-12 years) during surgery with general anaesthesia with bispectral index(BIS) in a tertiary hospital in The Netherlands.
Read the detailed description
Intraoperative non-invasive monitors designed to detect nociception during surgery have seen a considerable development over the past few years. There are multiple commercial monitoring devices available of which most have not been extensively evaluated in the pediatric population. Adequate levels of perioperative analgesia are important as they lead to less intraoperative nociception and less post-operative pain and post-operative complications and thereby leads to improved patient recovery. Monitoring the nociceptive state of a patient by monitoring the autonomic peripheral sympathetic pathways during surgery with these monitoring methods might lead to earlier detection of nociception and therefore less nociception and perioperative pain. Most monitoring devices have not been extensively evaluated in the pediatric population and have not yet demonstrated large clinical implications such as a decrease in post-operative pain or a decrease in opioid usage by using monitor guided analgesia administration. One of the nociception monitoring methods that has not been studied extensively in the pediatric population is the Nociception level index(NOL, Medasense, Ramat Gan, Israel). This monitor is a multi-parametric non-invasive monitoring method that measures heartrate, heartrate variability, skin temperature, photoplethysmographic amplitude, skin conductance and fluctuations in skin conductance using a non-invasive finger probe. These parameters are combined in an algorithm that provides an index from 0-100 with an abstract unit. With 0 indicating no nociception and 100 indicating severe nociception. A first study in the paediatric population with the NOL monitor showed that the NOL index was able to significantly detect first incision and significantly respond to opioid administration during surgery in children 1 to 5 years of age. Another more recent study demonstrated that the NOL index can quantify nociceptive stimuli in children aged 1 to 12. Other more commonly used monitoring methods for nociception such as fluctuations in mean arterial blood pressure(MAP), heartrate(HR) and respiratory rate(RR) did not show a significant change during first incision or during opioid administration in this study, indicating that the NOL monitor might be a better method to assess and respond to intraoperative nociception than fluctuations in MAP, HR and RR alone.
Another nociception monitoring method is the skin conduction algesimeter(SCA, Medstorm, Oslo, Norway. This is a single parameter nociception monitoring device that uses three electrodes that are fixed to the skin to measure fluctuations in skin conductance in order to detect nociception. It measures the amount of bursts in the skin sympatetic nerves in peaks per second. This contrasts with the multiparametric design of the NOL monitor with an algorithm and an abstract index of 0-100. The SCA monitor system doesn't utilize heartrate and photoplethysmographic amplitude. Hypothetically making the device less susceptible to interference of intraoperative hemodynamic changes and intraoperative vasoactive medication administration in comparison with the NOL monitor which does utilizes these variables in its system and algorithm. Furthermore as the SCA monitor measures the direct burst of the palmary or plantary sympathetic nerves this could mean that it responds faster than the NOL index to nociceptive stimuli. The SCA monitor has already been studied in the unanesthetized and the sedated pediatric and neonatal population. But has not seen extensive validation during surgery under general anaesthesia. One small pilot study in the pediatric population under general anaesthesia has been performed. In this study only 12 patients were included, and these patients had a broad age range (8.4 ± 5 years) and received perioperative analgesia through means of continuous infusion of remifentanil. Furthermore the studies researchers did not use the recommended threshold value for the SCA monitor. Both monitors use different proprietary owned algorithms with the same aim of detecting nociception.
Therefore, the primary goal of this study is to evaluate the SCA in the pediatric population during general anaesthesia. As more extensive evaluation of the SCA in the pediatric population is imperative in order to assess if it the SCA can detect nociceptive stimuli during general anesthesia. Another primary objective of this study will be to compare the SCA with the NOL index during general anesthesia. Evaluation of SCA through this feasibility study and comparison with the NOL monitor at the same time, may answer the question of which monitor can better predict and monitor nociceptive stimulation in the perioperative period. This will be the basis for future interventional randomized studies to assess if perioperative monitoring of the analgesia level leads to improved post-operative outcomes. We hypothesize that the NOL monitor and SCA monitor will both be able to quantify nociceptive stimuli, and that the SCA monitor responds faster than the NOL monitor.
Another secondary aim of the current study is the comparison of the BIS to the algesimeters awakening index.
Previous studies have demonstrated that fluctuations in skin conductance with an increase of area under the skin conductance peaks curve while awakening from general anesthesia performs similar to the bispectral index (BIS) in the adult population during nociceptive stimuli.
Primary Objectives:
- Evaluate if the SCA can detect nociceptive stimuli in children undergoing surgery with general anaesthesia.
- Compare the response of the SCA to the response of the NOL monitor during surgery with general anaesthesia.
Secondary Objective(s):
- Evaluate the response of the SCA and NOL to intraoperative opioid administration.
- Evaluate the response of the SCA and NOL index to intraoperative administration of vasoactive medication.
- Evaluate the response of the SCA and NOL to changes in mean arterial blood pressure (MAP, heartrate (HR) and respiratory rate (RR)
- Comparison of the SCA awakening index to the BIS.
- Comparison of the peak(maximum) values for NOL and SCA across both selected age groups (1-4 and 5-12)
- Comparison of the reaction time of both monitors after nociceptive stimulation.
- Compare the functionality of the NOL index and SCA monitor during general anesthesia and usage of localregional anesthesia.
- Conditions
- Nociceptive Pain, Anesthesia, Pain
- Being tested
- Connecting patients to both non-invasive monitors to observe and compare the monitor's capabilities.
- Keywords
- Nociception monitoring, Pediatric population
- Medical subject headings
- Nociceptive Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connecting patients to both non-invasive monitors to observe and compare the monitor's capabilities.Device
All patients will be connected to the NOL monitor and the SCA monitor during general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Patients aged 1 to 4 years of age | Patients will be connected to the NOL monitor and the SCA monitor during surgery with general anaesthesia. Receives: Device: Connecting patients to both non-invasive monitors to observe and compare the monitor's capabilities. | |
| Patients aged 5 to 12 years of age | Patients will be connected to the NOL monitor and the SCA monitor during surgery with general anaesthesia. Receives: Device: Connecting patients to both non-invasive monitors to observe and compare the monitor's capabilities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the SCA prior to and during a nociceptive event during the intraoperative period.
The pre stimulation values for SCA will be estimated by taking the peak(maximum) value -30 to 0 seconds before the occurrence of the nociceptive event. Post stimulation values for SCA will be estimated by taking the peak (maximum) value +0 to +30 seconds after the nociceptive event.
The SCA monitor records skin conductance in peaks per second. Varying from 0.00 peaks per second to 0,40 or more peaks per second. These peaks per second correlate with the pain index according to the manufacturer. With 0.00-0.06 peaks per second equalling pain index of zero and 0,40 or more peaks per second equalling a pain index of ten during surgical stimuli.
Measured: Through study completion, an average of 1 year
Changes in the NOL index prior to and during a nociceptive event during the intraoperative period.
The pre stimulation values for NOL will be estimated by taking the peak(maximum) value -30 to 0 seconds before the occurrence of the nociceptive event. Post stimulation values for NOL will be estimated by taking the peak (maximum) value +0 to +30 seconds after the nociceptive event.
The NOL index ranges from 0 to 100. With 0 indicating absence of nociception and 100 indicating severe nociception. The NOL index values are registered at a 5 second interval.
Measured: Through study completion, an average of 1 year
Correlation between changes in SCA and changes in NOL index during nociceptive events in the intraoperative period.
The pre stimulation values for SCA and NOL will be estimated by taking the peak(maximum) value -30 to 0 seconds before the occurrence of the nociceptive event. Post stimulation values for NOL and SCA will be estimated by taking the peak (maximum) value +0 to +30 seconds after the nociceptive event.
To compare the diagnostic performance of the SCA and the NOL index we will display data of the SCA and NOL index response to nociception stimuli in a scatterplot and we will perform an intraclass correlation coefficient calculation in order to assess if the response of the patients to the monitors correlate with each other.
The NOL index ranges from 0 to 100. With 0 indicating absence of nociception and 100 indicating severe nociception.
Measured: Through study completion, an average of 1 year
Secondary outcomes (12)
SCA response to opioid administration.
Response of the SCA to opioids administration is measured by comparing the peak (maximum) -20 to 0 seconds SCA value prior to fentanyl administration to the estimated peak (maximum) value +0-10 to 120-240 seconds after fentanyl administration. This is in accordance with known fentanyl pharmacokinetics in literature that states a maximum time to onset of 90 seconds
Measured: Through study completion, an average of 1 year.
NOL response to opioid administration.
Response of the NOL index to opioids administration is measured by comparing the peak (maximum) -20 to 0 seconds NOL index value prior to fentanyl administration to the estimated peak (maximum) value +0-10 to 120-240 seconds after fentanyl administration. This is in accordance with known fentanyl pharmacokinetics in literature that states a maximum time to onset of 90 seconds.
Measured: Through study completion, an average of 1 year.
SCA response to vasoactive medication administration.
The pre vasoactive medication values for SCA will be estimated by taking the peak(maximum) value -30 to 0 seconds before the occurrence of the nociceptive event. Post vasocative medication values for SCA will be estimated by taking the peak(maximum) value +0 to +30 seconds after the nociceptive event.
Measured: Through study completion, an average of 1 year.
NOL response to vasoactive medication administration.
The pre vasoactive medication values for NOL will be estimated by taking the peak(maximum) value -30 to 0 seconds before the occurrence of the nociceptive event. Post vasocative medication values for NOL will be estimated by taking the peak(maximum) value +0 to +30 seconds after the nociceptive event.
Measured: Through study completion, an average of 1 year.
Correlation between changes in the SCA compared to other predictors of nociception.
being heartrate, respiratory rate and non-invasive blood pressure data collected during nociceptive events. Data on non-invasive blood pressure is registered at a five-minute interval by the Intellivue Philips monitor (Koninklijke Philips N.V., 2004 - 2022). Data on respiratory rate is registered at a 1-minute interval by the Intellivue Philips monitor. Data on heartrate is registered at a 5 second interval by the PMD-200 monitor.
Measured: Through study completion, an average of 1 year.
Correlation between changes in the NOL index compared to other predictors of nociception
being heartrate, respiratory rate and non-invasive blood pressure data collected during nociceptive events. Data on non-invasive blood pressure is registered at a five-minute interval by the Intellivue Philips monitor (Koninklijke Philips N.V., 2004 - 2022). Data on respiratory rate is registered at a 1-minute interval by the Intellivue Philips monitor. Data on heartrate is registered at a 5 second interval by the PMD-200 monitor.
Measured: Through study completion, an average of 1 year.
BIS monitor response to intraoperative nociceptive stimuli
During intra-operative nociceptive events SCA awakening index and BIS will be compared in order to assess their similarity when assessing awakening from nociceptive stimuli. Appropriate statistical analysis will be performed according to the distribution of data regarding BIS and SCA awakening index.
BIS values range from 0 to 100. A value of 0 represents the absence of brain activity, and 100 represents the awake state.
Measured: Through study completion, an average of 1 year.
SCA awakening index response to intraoperative nociceptive stimuli
During intra-operative nociceptive events SCA awakening index and BIS will be compared in order to assess their similarity when assessing awakening from nociceptive stimuli. Appropriate statistical analysis will be performed according to the distribution of data regarding BIS and SCA awakening index.
Measured: Through study completion, an average of 1 year.
Peak values for NOL and SCA for age group 1-4 years
Pre stimulus peak values (-30 to 0+) will be compared to post stimulus peak values (0+ to 30+).
Measured: Through study completion, an average of 1 year.
Peak values for NOL and SCA for age group 5-12 years
Pre stimulus peak values (-30 to 0+) will be compared to post stimulus peak values (0+ to 30+).
Measured: Through study completion, an average of 1 year.
Reaction time NOL and SCA
Comparison of average reaction time in seconds of NOL and SCA after nociceptive stimuli/event. measured in seconds.
Measured: Through study completion, an average of 1 year.
NOL and SCA reaction during locoregional anaesthesia technique
Pre stimulus peak values (-30 to 0+) will be compared to post stimulus peak values (0+ to 30+) for both NOL and SCA for nociceptive stimuli placed inside area of the skin covered bij locoregional blockade.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start29 Sep 2023
- Primary completion25 Oct 2024
- Study completion25 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Nociceptive PainStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998564
- Sponsor's protocol ID
- 2023-16214
- Other IDs
- 2023
- Acronym
- NOLvsSCA
- Status last verified
- Jun 2023
- First submitted
- 25 Jul 2023
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There are plans to publish the findings and the participants and their caregivers will be informed of this during the informed consent procedure.
Publications
Ledowski T. Objective monitoring of nociception: a review of current commercial solutions. Br J Anaesth. 2019 Aug;123(2):e312-e321. doi: 10.1016/j.bja.2019.03.024. Epub 2019 Apr 30.
PubMed 31047645Sabourdin N, Constant I. Monitoring of analgesia level during general anesthesia in children. Curr Opin Anaesthesiol. 2022 Jun 1;35(3):367-373. doi: 10.1097/ACO.0000000000001141.
PubMed 35671026Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.
PubMed 29026331Ferland CE, Vega E, Ingelmo PM. Acute pain management in children: challenges and recent improvements. Curr Opin Anaesthesiol. 2018 Jun;31(3):327-332. doi: 10.1097/ACO.0000000000000579.
PubMed 29432292Ben-Israel N, Kliger M, Zuckerman G, Katz Y, Edry R. Monitoring the nociception level: a multi-parameter approach. J Clin Monit Comput. 2013 Dec;27(6):659-68. doi: 10.1007/s10877-013-9487-9. Epub 2013 Jul 9.
PubMed 23835792Klein Tank C, Himantono N, van Uitert A, Malagon I. Evaluation of the nociception level index in the pediatric population: An observational feasibility study. Paediatr Anaesth. 2023 Jun;33(6):495-496. doi: 10.1111/pan.14632. Epub 2023 Jan 22. No abstract available.
PubMed 36645161Storm H. Changes in skin conductance as a tool to monitor nociceptive stimulation and pain. Curr Opin Anaesthesiol. 2008 Dec;21(6):796-804. doi: 10.1097/ACO.0b013e3283183fe4.
PubMed 18997532Chemam 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 36863410Storm H. Skin conductance and the stress response from heel stick in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2000 Sep;83(2):F143-7. doi: 10.1136/fn.83.2.f143.
PubMed 10952711Harrison D, Boyce S, Loughnan P, Dargaville P, Storm H, Johnston L. Skin conductance as a measure of pain and stress in hospitalised infants. Early Hum Dev. 2006 Sep;82(9):603-8. doi: 10.1016/j.earlhumdev.2005.12.008. Epub 2006 Feb 28.
PubMed 16507342Walas W, Halaba Z, Kubiaczyk A, Piotrowski A, Latka-Grot J, Szczapa T, Romul M, Maroszynska I, Malinowska E, Rutkowska M, Skrzypek M, Smigiel R. Skin conductance measurement for the assessment of analgosedation adequacy in infants treated with mechanical ventilation: A multicenter pilot study. Adv Clin Exp Med. 2020 Sep;29(9):1117-1121. doi: 10.17219/acem/126286.
PubMed 32937040Karpe J, Misiolek A, Daszkiewicz A, Misiolek H. Objective assessment of pain-related stress in mechanically ventilated newborns based on skin conductance fluctuations. Anaesthesiol Intensive Ther. 2013 Jul-Sep;45(3):134-7. doi: 10.5603/AIT.2013.0028.
PubMed 24092508Sabourdin N, Arnaout M, Louvet N, Guye ML, Piana F, Constant I. Pain monitoring in anesthetized children: first assessment of skin conductance and analgesia-nociception index at different infusion rates of remifentanil. Paediatr Anaesth. 2013 Feb;23(2):149-55. doi: 10.1111/pan.12071. Epub 2012 Nov 21.
PubMed 23170802Storm H. "Pain monitoring in anesthetized children: first assessment of skin conductance and analgesia-nociception index at different infusion rates of remifentanil", recommended preset values for the skin conductance equipment was not used. Paediatr Anaesth. 2013 Aug;23(8):761-3. doi: 10.1111/pan.12203. No abstract available.
PubMed 23822183Ledowski T, Paech MJ, Storm H, Jones R, Schug SA. Skin conductance monitoring compared with bispectral index monitoring to assess emergence from general anaesthesia using sevoflurane and remifentanil. Br J Anaesth. 2006 Aug;97(2):187-91. doi: 10.1093/bja/ael119. Epub 2006 May 23.
PubMed 16720673
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Skin Conductance Algesimeter and the Nociception Level Index in the Paediatric Population. An Observational Study.
- ClinicalTrials.gov ID
- NCT05998564
- Acronym / sponsor ID
- NOLvsSCA / 2023-16214
- Conditions
- Nociceptive Pain, Anesthesia, Pain
- Keywords
- Nociception monitoring, Pediatric population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 21 Aug 2023 (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.
Evaluation and comparison of the skin conductance algesimeter(SCA) and the nociception level index(NOL) in the paediatric population (1-12 years) during surgery with general anaesthesia with bispectral index(BIS) in a tertiary hospital in The Netherlands.
Detailed description
Intraoperative non-invasive monitors designed to detect nociception during surgery have seen a considerable development over the past few years. There are multiple commercial monitoring devices available of which most have not been extensively evaluated in the pediatric population. Adequate levels of perioperative analgesia are important as they lead to less intraoperative nociception and less post-operative pain and post-operative complications and thereby leads to improved patient recovery. Monitoring the nociceptive state of a patient by monitoring the autonomic peripheral sympathetic pathways during surgery with these monitoring methods might lead to earlier detection of nociception and therefore less nociception and perioperative pain. Most monitoring devices have not been extensively evaluated in the pediatric population and have not yet demonstrated large clinical implications such as a decrease in post-operative pain or a decrease in opioid usage by using monitor guided analgesia administration. One of the nociception monitoring methods that has not been studied extensively in the pediatric population is the Nociception level index(NOL, Medasense, Ramat Gan, Israel). This monitor is a multi-parametric non-invasive monitoring method that measures heartrate, heartrate variability, skin temperature, photoplethysmographic amplitude, skin conductance and fluctuations in skin conductance using a non-invasive finger probe. These parameters are combined in an algorithm that provides an index from 0-100 with an abstract unit. With 0 indicating no nociception and 100 indicating severe nociception. A first study in the paediatric population with the NOL monitor showed that the NOL index was able to significantly detect first incision and significantly respond to opioid administration during surgery in children 1 to 5 years of age. Another more recent study demonstrated that the NOL index can quantify nociceptive stimuli in children aged 1 to 12. Other more commonly used monitoring methods for nociception such as fluctuations in mean arterial blood pressure(MAP), heartrate(HR) and respiratory rate(RR) did not show a significant change during first incision or during opioid administration in this study, indicating that the NOL monitor might be a better method to assess and respond to intraoperative nociception than fluctuations in MAP, HR and RR alone.
Another nociception monitoring method is the skin conduction algesimeter(SCA, Medstorm, Oslo, Norway. This is a single parameter nociception monitoring device that uses three electrodes that are fixed to the skin to measure fluctuations in skin conductance in order to detect nociception. It measures the amount of bursts in the skin sympatetic nerves in peaks per second. This contrasts with the multiparametric design of the NOL monitor with an algorithm and an abstract index of 0-100. The SCA monitor system doesn't utilize heartrate and photoplethysmographic amplitude. Hypothetically making the device less susceptible to interference of intraoperative hemodynamic changes and intraoperative vasoactive medication administration in comparison with the NOL monitor which does utilizes these variables in its system and algorithm. Furthermore as the SCA monitor measures the direct burst of the palmary or plantary sympathetic nerves this could mean that it responds faster than the NOL index to nociceptive stimuli. The SCA monitor has already been studied in the unanesthetized and the sedated pediatric and neonatal population. But has not seen extensive validation during surgery under general anaesthesia. One small pilot study in the pediatric population under general anaesthesia has been performed. In this study only 12 patients were included, and these patients had a broad age range (8.4 ± 5 years) and received perioperative analgesia through means of continuous infusion of remifentanil. Furthermore the studies researchers did not use the recommended threshold value for the SCA monitor. Both monitors use different proprietary owned algorithms with the same aim of detecting nociception.
Therefore, the primary goal of this study is to evaluate the SCA in the pediatric population during general anaesthesia. As more extensive evaluation of the SCA in the pediatric population is imperative in order to assess if it the SCA can detect nociceptive stimuli during general anesthesia. Another primary objective of this study will be to compare the SCA with the NOL index during general anesthesia. Evaluation of SCA through this feasibility study and comparison with the NOL monitor at the same time, may answer the question of which monitor can better predict and monitor nociceptive stimulation in the perioperative period. This will be the basis for future interventional randomized studies to assess if perioperative monitoring of the analgesia level leads to improved post-operative outcomes. We hypothesize that the NOL monitor and SCA monitor will both be able to quantify nociceptive stimuli, and that the SCA monitor responds faster than the NOL monitor.
Another secondary aim of the current study is the comparison of the BIS to the algesimeters awakening index.
Previous studies have demonstrated that fluctuations in skin conductance with an increase of area under the skin conductance peaks curve while awakening from general anesthesia performs similar to the bispectral index (BIS) in the adult population during nociceptive stimuli.
Primary Objectives:
- Evaluate if the SCA can detect nociceptive stimuli in children undergoing surgery with general anaesthesia.
- Compare the response of the SCA to the response of the NOL monitor during surgery with general anaesthesia.
Secondary Objective(s):
- Evaluate the response of the SCA and NOL to intraoperative opioid administration.
- Evaluate the response of the SCA and NOL index to intraoperative administration of vasoactive medication.
- Evaluate the response of the SCA and NOL to changes in mean arterial blood pressure (MAP, heartrate (HR) and respiratory rate (RR)
- Comparison of the SCA awakening index to the BIS.
- Comparison of the peak(maximum) values for NOL and SCA across both selected age groups (1-4 and 5-12)
- Comparison of the reaction time of both monitors after nociceptive stimulation.
- Compare the functionality of the NOL index and SCA monitor during general anesthesia and usage of localregional anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients aged 1 to 4 years of age | – | Device: Connecting patients to both non-invasive monitors to observe and compare the monitor's capabilities.Patients will be connected to the NOL monitor and the SCA monitor during surgery with general anaesthesia. |
| Patients aged 5 to 12 years of age | – | Device: Connecting patients to both non-invasive monitors to observe and compare the monitor's capabilities.Patients will be connected to the NOL monitor and the SCA monitor during surgery with general anaesthesia. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- A total of 50 patients. 25 patients aged 1-4 years old, and 25 patients aged 5-12 years old that are scheduled to undergo elective surgery under general anaesthesia. Patients will be enrolled after obtaining written informed consent. We decided to evaluate the SCA and NOL index in two age groups because of the significant differences of maturations of the bodies across different ages that might influence the measurements made by the SCA and NOL monitor. Furthermore the maturation of the brain of a paediatric patient also differs significantly across different ages. Leading to significant differences in EEG patterns and corresponding BIS monitor values across age groups 1-4 and groups 5-11. Therefore, assessing the NOL and SCA in these two difference age groups results in a better ability to assess the homogeneity of the population as we will also be able to quantify and compare the depth of anesthesia through BIS monitor in these two age groups.
Key inclusion criteria (5 listed)
- Male or female
- ASA I, ASA II and ASA III
- Aged 1 to 12 years old
- Scheduled to undergo elective surgery with general anaesthesia
- Written informed consent obtained from subject or/and subject's legal representatives.
Key exclusion criteria (3 listed)
- Known allergy to the adhesive tape used in the sensors.
- Patients that do not meet the inclusion criteria will be excluded.
- No free available limb to attach the probes to.
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 |
|---|---|---|
| Connecting patients to both non-invasive monitors to observe and compare the monitor's capabilities.All patients will be connected to the NOL monitor and the SCA monitor during general anesthesia. | Device | Patients aged 1 to 4 years of age, Patients aged 5 to 12 years of age |
Primary outcome
Changes in the SCA prior to and during a nociceptive event during the intraoperative period.
Time frame: Through study completion, an average of 1 year
The pre stimulation values for SCA will be estimated by taking the peak(maximum) value -30 to 0 seconds before the occurrence of the nociceptive event. Post stimulation values for SCA will be estimated by taking the peak (maximum) value +0 to +30 seconds after the nociceptive event. The SCA monitor records skin conductance in peaks per second. Varying from 0.00 peaks per second to 0,40 or more peaks per second. These peaks per second correlate with the pain index according to the manufacturer. With 0.00-0.06 peaks per second equalling pain index of zero and 0,40 or more peaks per second equalling a pain index of ten during surgical stimuli.
Changes in the NOL index prior to and during a nociceptive event during the intraoperative period.
Time frame: Through study completion, an average of 1 year
The pre stimulation values for NOL will be estimated by taking the peak(maximum) value -30 to 0 seconds before the occurrence of the nociceptive event. Post stimulation values for NOL will be estimated by taking the peak (maximum) value +0 to +30 seconds after the nociceptive event. The NOL index ranges from 0 to 100. With 0 indicating absence of nociception and 100 indicating severe nociception. The NOL index values are registered at a 5 second interval.
Correlation between changes in SCA and changes in NOL index during nociceptive events in the intraoperative period.
Time frame: Through study completion, an average of 1 year
The pre stimulation values for SCA and NOL will be estimated by taking the peak(maximum) value -30 to 0 seconds before the occurrence of the nociceptive event. Post stimulation values for NOL and SCA will be estimated by taking the peak (maximum) value +0 to +30 seconds after the nociceptive event. To compare the diagnostic performance of the SCA and the NOL index we will display data of the SCA and NOL index response to nociception stimuli in a scatterplot and we will perform an intraclass correlation coefficient calculation in order to assess if the response of the patients to the monitors correlate with each other. The NOL index ranges from 0 to 100. With 0 indicating absence of nociception and 100 indicating severe nociception.
12 secondary outcomes
SCA response to opioid administration.
Time frame: Through study completion, an average of 1 year.
NOL response to opioid administration.
Time frame: Through study completion, an average of 1 year.
SCA response to vasoactive medication administration.
Time frame: Through study completion, an average of 1 year.
NOL response to vasoactive medication administration.
Time frame: Through study completion, an average of 1 year.
Correlation between changes in the SCA compared to other predictors of nociception.
Time frame: Through study completion, an average of 1 year.
Correlation between changes in the NOL index compared to other predictors of nociception
Time frame: Through study completion, an average of 1 year.
BIS monitor response to intraoperative nociceptive stimuli
Time frame: Through study completion, an average of 1 year.
SCA awakening index response to intraoperative nociceptive stimuli
Time frame: Through study completion, an average of 1 year.
Peak values for NOL and SCA for age group 1-4 years
Time frame: Through study completion, an average of 1 year.
Peak values for NOL and SCA for age group 5-12 years
Time frame: Through study completion, an average of 1 year.
Reaction time NOL and SCA
Time frame: Through study completion, an average of 1 year.
NOL and SCA reaction during locoregional anaesthesia technique
Time frame: Through study completion, an average of 1 year.
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 7 Jan 2026.
- Background: PubMed 31047645Ledowski T. Objective monitoring of nociception: a review of current commercial solutions. Br J Anaesth. 2019 Aug;123(2):e312-e321. doi: 10.1016/j.bja.2019.03.024. Epub 2019 Apr 30.
- Background: PubMed 35671026Sabourdin N, Constant I. Monitoring of analgesia level during general anesthesia in children. Curr Opin Anaesthesiol. 2022 Jun 1;35(3):367-373. doi: 10.1097/ACO.0000000000001141.
- Background: PubMed 29026331Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.
- Background: PubMed 29432292Ferland CE, Vega E, Ingelmo PM. Acute pain management in children: challenges and recent improvements. Curr Opin Anaesthesiol. 2018 Jun;31(3):327-332. doi: 10.1097/ACO.0000000000000579.
- Background: PubMed 23835792Ben-Israel N, Kliger M, Zuckerman G, Katz Y, Edry R. Monitoring the nociception level: a multi-parameter approach. J Clin Monit Comput. 2013 Dec;27(6):659-68. doi: 10.1007/s10877-013-9487-9. Epub 2013 Jul 9.
- Background: PubMed 36645161Klein Tank C, Himantono N, van Uitert A, Malagon I. Evaluation of the nociception level index in the pediatric population: An observational feasibility study. Paediatr Anaesth. 2023 Jun;33(6):495-496. doi: 10.1111/pan.14632. Epub 2023 Jan 22. No abstract available.
- Background: PubMed 18997532Storm H. Changes in skin conductance as a tool to monitor nociceptive stimulation and pain. Curr Opin Anaesthesiol. 2008 Dec;21(6):796-804. doi: 10.1097/ACO.0b013e3283183fe4.
- Background: 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.
- Background: PubMed 10952711Storm H. Skin conductance and the stress response from heel stick in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2000 Sep;83(2):F143-7. doi: 10.1136/fn.83.2.f143.
- Background: PubMed 16507342Harrison D, Boyce S, Loughnan P, Dargaville P, Storm H, Johnston L. Skin conductance as a measure of pain and stress in hospitalised infants. Early Hum Dev. 2006 Sep;82(9):603-8. doi: 10.1016/j.earlhumdev.2005.12.008. Epub 2006 Feb 28.
- Background: PubMed 32937040Walas W, Halaba Z, Kubiaczyk A, Piotrowski A, Latka-Grot J, Szczapa T, Romul M, Maroszynska I, Malinowska E, Rutkowska M, Skrzypek M, Smigiel R. Skin conductance measurement for the assessment of analgosedation adequacy in infants treated with mechanical ventilation: A multicenter pilot study. Adv Clin Exp Med. 2020 Sep;29(9):1117-1121. doi: 10.17219/acem/126286.
- Background: PubMed 24092508Karpe J, Misiolek A, Daszkiewicz A, Misiolek H. Objective assessment of pain-related stress in mechanically ventilated newborns based on skin conductance fluctuations. Anaesthesiol Intensive Ther. 2013 Jul-Sep;45(3):134-7. doi: 10.5603/AIT.2013.0028.
- Individual participant dataSharing planned: Undecided. There are plans to publish the findings and the participants and their caregivers will be informed of this during the informed consent procedure.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nociceptive Pain and Anesthesia, run by Radboud University Medical Center at 1 site in Netherlands.
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 5 inclusion and 3 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 7 Jan 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 Netherlands. 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?
Changes in the SCA prior to and during a nociceptive event during the intraoperative period. (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 NCT05998564, which also lists 20 linked publications.
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 7 Jan 2026.