Comparison of the Skin Conductance Algesimeter and the Nociception Level Index in the Paediatric Population. An Observational Study.

NCT05998564 | Completed

• 1 other identifier: 2023-16214
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Nociceptive Pain; Anesthesia; Pain

Keywords

Nociception monitoring; Pediatric population

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Through study completion, an average of 1 year

Secondary Outcomes (12)

• SCA response to opioid administration.

  Through study completion, an average of 1 year.

• NOL response to opioid administration.

  Through study completion, an average of 1 year.

• SCA response to vasoactive medication administration.

  Through study completion, an average of 1 year.

• NOL response to vasoactive medication administration.

  Through study completion, an average of 1 year.

• Correlation between changes in the SCA compared to other predictors of nociception.

  Through study completion, an average of 1 year.

Study Arms (2)

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.

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.

Device: Connecting patients to both non-invasive monitors to observe and compare the monitor's capabilities.

Interventions

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.

Patients aged 1 to 4 years of age; Patients aged 5 to 12 years of age

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Known allergy to the adhesive tape used in the sensors.
• No free available limb to attach the probes to.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, Netherlands

Location

Related Publications (20)

• 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.

  PMID: 31047645 BACKGROUND

• Sabourdin 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.

  PMID: 35671026 BACKGROUND

• Gan 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.

  PMID: 29026331 BACKGROUND

• Ferland 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.

  PMID: 29432292 BACKGROUND

• Ben-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.

  PMID: 23835792 BACKGROUND

• Klein 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.

  PMID: 36645161 BACKGROUND

• Storm 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.

  PMID: 18997532 BACKGROUND

• 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.

  PMID: 36863410 BACKGROUND

• Storm 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.

  PMID: 10952711 BACKGROUND

• Harrison 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.

  PMID: 16507342 BACKGROUND

• Walas 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.

  PMID: 32937040 BACKGROUND

• Karpe 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.

  PMID: 24092508 BACKGROUND

• Sabourdin 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.

  PMID: 23170802 BACKGROUND

• Storm 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.

  PMID: 23822183 BACKGROUND

• Ledowski 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.

  PMID: 16720673 BACKGROUND

• Ledowski T, Bromilow J, Paech MJ, Storm H, Hacking R, Schug SA. Skin conductance monitoring compared with Bispectral Index to assess emergence from total i.v. anaesthesia using propofol and remifentanil. Br J Anaesth. 2006 Dec;97(6):817-21. doi: 10.1093/bja/ael278. Epub 2006 Oct 22.

  PMID: 17060330 BACKGROUND

• Davidson A, Skowno J. Neuromonitoring in paediatric anaesthesia. Curr Opin Anaesthesiol. 2019 Jun;32(3):370-376. doi: 10.1097/ACO.0000000000000732.

  PMID: 30893116 BACKGROUND

• Wang F, Zhang J, Yu J, Tian M, Cui X, Wu A. Variation of bispectral index in children aged 1-12 years under propofol anesthesia: an observational study. BMC Anesthesiol. 2019 Aug 7;19(1):145. doi: 10.1186/s12871-019-0815-6.

  PMID: 31390975 BACKGROUND

• Ziesenitz VC, Vaughns JD, Koch G, Mikus G, van den Anker JN. Pharmacokinetics of Fentanyl and Its Derivatives in Children: A Comprehensive Review. Clin Pharmacokinet. 2018 Feb;57(2):125-149. doi: 10.1007/s40262-017-0569-6.

  PMID: 28688027 BACKGROUND

• Edry R, Recea V, Dikust Y, Sessler DI. Preliminary Intraoperative Validation of the Nociception Level Index: A Noninvasive Nociception Monitor. Anesthesiology. 2016 Jul;125(1):193-203. doi: 10.1097/ALN.0000000000001130.

  PMID: 27171828 BACKGROUND

MeSH Terms

Conditions

Nociceptive Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 21, 2023
• Study Start: September 29, 2023
• Primary Completion: October 25, 2024
• Study Completion: October 25, 2024
• Last Updated: January 7, 2026

Record last verified: 2023-06

Locations

NL (1)