Comparison of the Surgical Pleth Index and the Nociception Level Index in the Pediatric Population
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-12
SponsorRadboud University Medical Center
About this trial
This observational study aims to compare two nociception monitoring methods. The Nociception Level (NOL) index and the Surgical Pleth Index (SPI) in the pediatric population during general anesthesia. While both monitors are designed to assess nociceptive responses through autonomic nervous system activity, they differ in methodology and parameters measured. The NOL index integrates multiple physiological signals using a self-learning algorithm, while SPI focuses on heart rate variability and plethysmographic amplitude. Although both have been studied individually in children, a direct comparison has not yet been conducted. This study will evaluate and compare each monitor's ability to detect and quantify nociceptive stimuli (surgical and tetanic) in children.
The investigators hypothesize that the NOL monitor and SPI monitor will both be able to quantify surgical stimuli and tetanic stimuli with monitors response to surgical stimuli \> monitors response to tetanic stimuli. However, the investigators also hypothesize that the NOL index will do this superiorly, as it utilizes a self-learning algorithm and more parameters are incorporated in its algorithm
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female
ASA I, ASA II and ASA III
Aged 1 to 12 years old
Scheduled to undergo elective surgery with general anaesthesia
Disqualifiers
Patients with chronic pain
Patients with chronic analgesia usage.
Known allergy to the adhesives used in the sensors.
No free available limb to attach the probes to.
Trial population
pediatric patients scheduled to undergo surgery with general anesthesia at the Radboud university medical centre in Nijmegen, the Netherlands
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Connecting all patients to the nociception level index(NOL) and the surgical pleth index (SPI)
DeviceAll patients will be connected to the NOL and SPI during surgery after induction of general anesthesia.
All patient will receive a tetanic stimuli (60mA, 100hz) of 5 seconds before start of incision
DeviceAll patient will receive a tetanic stimuli (60mA, 100hz) of 5 seconds before start of incision.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Patients aged 1 to 12 years undergoing surgery with general anesthesia.2 interventions
Trial outcomes
Primary outcomes
1
Change in surgical pleth index (∆SPI) during surgical stimuli and standardized tetanic stimuli
∆SPI = pre stimulus -30s-0s mean SPI value - post stimulus +5s to 30s-120s SPI value.
Time frame
During surgery with general anesthesia.2
Change in nociception level index (∆NOL) during surgical stimuli and standardized tetanic stimuli
∆NOL = pre stimulus -30s-0s mean NOL value - post stimulus +5s to 30s-120s NOL value.
Time frame
During surgery with general anesthesiaSecondary outcomes
1
Change in surgical pleth index (∆SPI) following intraoperative opioid administration.
Response of the SPI to intraoperative administration of opioids. Evaluate SPI mean values -20s to 0s before opioid administration to mean value after opioid administration in accordance with the utilized opiod farmacokinetics(time of mean measurement in seconds depends on opioid used).
Time frame
During surgery with general anesthesia]2
Change in nociception level index (∆NOL) following intraoperative opioid administration.
Response of the NOL index to intraoperative administration of opioids. Evaluate NOL mean values -20s to 0s before opioid administration to mean value after opioid administration in accordance with the utilized opiod farmacokinetics(time of mean measurement in seconds depends on opioid used).
Time frame
During surgery with general anesthesia3
Time NOL index is >25 and SPI is >40 during surgery and before intra-operative opioid administration. Defined as time NOL index is >20-25 and SPI is >40 during surgery time.
Defined as time in seconds NOL index is \>25 and SPI is \>40 during surgery time.
Time frame
During surgery with general anesthesia4
Comparing mean (total surgery time) and last 5-min mean values before disconnection for intra-operative NOL and SPI to the post-operative pain scores.
* For patients aged \<4 Faces, legs, activity, cry and consolability (FLACC) will be used * For patients aged \>4 a faces pain scale, numeric rating scale (NRS) or visual analogue scale (VAS) will be used. * Pain scores will be obtained at recovery admittance, after one hour and at recovery departure and when recovery personnel deem it is necessary based on their clinical view.
Time frame
perioperative/periproceduralSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov