Observing and Comparing Two Pain Monitoring Devices During Surgery in Children Aged 1 to 12 Years

What this Trial Is About

Researchers are evaluating two different devices that monitor nociception, or the bodys response to painful stimuli, in children aged 1 to 12 years during general anesthesia. This observational study compares the Nociception Level NOL index, which uses a self-learning algorithm combining several physiological signals, with the Surgical Pleth Index SPI, which measures heart rate variability and blood flow changes. Although both devices have been studied individually, this is the first direct comparison in the pediatric population to assess their ability to detect and measure surgical and tetanic pain stimuli. During surgery, children will be connected to both the NOL and SPI monitoring devices immediately after anesthesia induction. Before the surgical incision, a standardized tetanic stimulus lasting 5 seconds at 60 mA and 100 Hz will be applied to the ulnar nerve to simulate a controlled pain response. The study will record responses to various nociceptive events such as intubation, airway insertion, surgical incision, and opioid administration. After surgery, patients will be disconnected from the monitors, and post-operative pain and comfort scores, as well as analgesia use, will be documented. Participants will be evaluated throughout their surgery with continuous monitoring of heart rate, respiratory rate, blood pressure, neuromuscular activity, and brain activity using standard anesthesia protocols alongside the nociception devices. Researchers will measure changes in NOL and SPI indices during surgical and tetanic stimuli, responses to opioid and vasoactive medication, and correlate these with post-operative pain scores. The study is expected to last approximately one year and aims to provide detailed insights into how these monitors perform in real pediatric surgical settings.

Comparison of the Surgical Pleth Index and the Nociception Level Index in the Pediatric Population