Clinical trial NCT05998564: Comparison of the Skin Conductance Algesimeter and the Nociception Level Index in the Paediatric Population. an Observational Study.
Official title: Comparison of the Skin Conductance Algesimeter and the Nociception Level Index in the Paediatric Population. an Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nociceptive Pain
Anesthesia
Pain
Keywords: Nociception monitoring
Pediatric population
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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:

1. Evaluate if the SCA can detect nociceptive stimuli in children undergoing surgery with general anaesthesia.
2. Compare the response of the SCA to the response of the NOL monitor during surgery with general anaesthesia.

Secondary Objective(s):

1. Evaluate the response of the SCA and NOL to intraoperative opioid administration.
2. Evaluate the response of the SCA and NOL index to intraoperative administration of vasoactive medication.
3. Evaluate the response of the SCA and NOL to changes in mean arterial blood pressure (MAP, heartrate (HR) and respiratory rate (RR)
4. Comparison of the SCA awakening index to the BIS.
5. Comparison of the peak(maximum) values for NOL and SCA across both selected age groups (1-4 and 5-12)
6. Comparison of the reaction time of both monitors after nociceptive stimulation.
7. Compare the functionality of the NOL index and SCA monitor during general anesthesia and usage of localregional anesthesia.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in the SCA prior to and during a nociceptive event during the intraoperative period.
timeFrame: Through study completion, an average of 1 year
measure: Changes in the NOL index prior to and during a nociceptive event during the intraoperative period.
timeFrame: Through study completion, an average of 1 year
measure: Correlation between changes in SCA and changes in NOL index during nociceptive events in the intraoperative period.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: SCA response to opioid administration.
timeFrame: Through study completion, an average of 1 year.
measure: NOL response to opioid administration.
timeFrame: Through study completion, an average of 1 year.
measure: SCA response to vasoactive medication administration.
timeFrame: Through study completion, an average of 1 year.
measure: NOL response to vasoactive medication administration.
timeFrame: Through study completion, an average of 1 year.
measure: Correlation between changes in the SCA compared to other predictors of nociception.
timeFrame: Through study completion, an average of 1 year.
measure: Correlation between changes in the NOL index compared to other predictors of nociception
timeFrame: Through study completion, an average of 1 year.
measure: BIS monitor response to intraoperative nociceptive stimuli
timeFrame: Through study completion, an average of 1 year.
measure: SCA awakening index response to intraoperative nociceptive stimuli
timeFrame: Through study completion, an average of 1 year.
measure: Peak values for NOL and SCA for age group 1-4 years
timeFrame: Through study completion, an average of 1 year.
measure: Peak values for NOL and SCA for age group 5-12 years
timeFrame: Through study completion, an average of 1 year.
measure: Reaction time NOL and SCA
timeFrame: Through study completion, an average of 1 year.
measure: NOL and SCA reaction during locoregional anaesthesia technique
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
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