Clinical Research Directory

AI-Assisted Analgesia Copilot System

The primary objective of the SEASCAPE project is to design, develop, and to apply a clinical implementation tool of a machine learning (ML) and artificial intelligence (AI)-based co-pilot system for the real-time monitoring and control of nociception during general anesthesia (GA). The ultimate clinical purpose is to optimize individualized pain management by achieving precise titration of intravenous opioids (specifically remifentanil), thereby minimizing the incidence of over- and under-dosing. This optimization is projected to enhance patient outcomes, reduce opioid-related complications, and improve overall cost-effectiveness of anesthetic procedures. The main scientific question guiding this work is: Can a novel algorithm be generated and validated to provide superior analytical precision for analgesic management by reliably differentiating genuine nociceptive responses from confounding physiological variables-such as inadequate neuromuscular blockade or changes in depth of anesthesia-thereby significantly improving the clinical decision-making framework for intraoperative nociception control? This project addresses the recognized challenge in anesthesiology: defining an objective measure to quantify nociception and antinociception during GA. Study Population: Patients scheduled for elective surgical procedures requiring general anesthesia (GA). Existing Intervention: The standard anesthetic regimen includes continuous intravenous infusion of the remifentanil for intraoperative analgesia, typically governed by a Target Controlled Infusion (TCI) system utilizing a pharmacokinetic/pharmacodynamic (PK/PD) model (Eleveld TCI model). Project Focus: The research seeks to improve the accuracy and efficacy of this existing analgesic strategy by integrating a multivariate patient data stream with the newly developed SEASCAPE co-pilot AI. This aims to refine the remifentanil dose predictions beyond the current TCI model's capabilities, personalized system.

Nociception Monitoring During Cardiac Surgery

Cardiac surgery is frequently a source of acute or chronic pain. According to the International Association for the Study of Pain (IASP), nociception is defined as "the neural mechanisms of encoding and processing harmful stimuli," while pain is defined as "an undesirable sensory and emotional experience associated with real tissue damage". When patients are under general anesthesia (GA) during surgery, a lack of intraoperative analgesia can expose them to high levels of pain sensitization associated with surgical nociceptive stimuli. The response to the surgical nociceptive stress (via activation of the autonomic nervous system) can lead to alterations in hemodynamic or metabolic status, coagulation or the immune system. In addition, it is now well established that acute intra- and post-operative pain is directly related to the onset of chronic pain, particularly in the post-sternotomy period. On the contrary, excessive administration of opioid analgesics causes moderate to severe side effects (nausea, vomiting, bradypnea, delayed awakening, prolongation of recovery time, hyperalgesia syndrome, postoperative tolerance to opioids leading to misuse or occurrence of DCPO), which will result in postoperative morbidity for the patient independent of the surgery. Indeed, in cardiac surgery, there is a dose-dependent relationship between the intraoperative use of opioid analgesics such as remifentanil and the occurrence of postoperative hyperalgesia. The interest in intraoperative monitoring of nociception has therefore clearly increased in order to improve patient care from the point of view of intra- and postoperative pain management: administering a sufficient and personalized dose of analgesics, neither too high nor too low. Strategies to prevent perioperative pain must therefore be developed to avoid sensitizing the patient to pain and thus limiting the onset of CD, or conversely, to avoid the onset of side effects from excessive analgesic treatment. These strategies include intra-operative pain monitoring. Numerous medical devices are available on the market to measure the level of nociception in patients undergoing GA. The vast majority of these monitors analyse clinical parameters that assess the balance between the sympathetic and parasympathetic nervous systems. Of all the monitors available, there is currently only one multiparametric monitor, the PMD200® which provides the Nociception Level Index or NOL Index (Medasense, Ramat Gan, Israel). In fact, the latter incorporates 5 parameters in its assessment of nociception: heart rate, RR segment variability, pulse wave amplitude, skin conductance level and skin temperature with the number of variations of these last two parameters. New devices for monitoring nociception used in the administration of intraoperative intravenous opioid agents could help to adjust the analgesia/nociception balance. In non-cardiac surgery, the NOL index has shown better sensitivity and specificity than variations in heart rate and blood pressure in detecting and helping to manage a surgical nociceptive stimulus during GA. This monitor has also enabled a dramatic reduction in the doses of intraoperative opioids administered. In this study we hypothesized that monitoring of nociception using the NOL index is feasible during coronary artery surgery despite extracorporeal circulation.

Quantitative Consciousness Index Monitoring (qNOX) of Sedation During Endoscopy

Nociception is the encoding and processing of noxious stimulation and is considered an objective indicator for monitoring pain. Currently, a new clinically-applied medical-engineering integrated monitoring device for noxious stimulation response has emerged. Its fundamental principle is based on the monitoring of electroencephalographic (EEG) activity, incorporating two monitoring parameters: the quantitative consciousness (qCON) index and the quantitative nociceptive (qNOX) index. This device enables more precise monitoring of anesthesia depth, quantification of patients' anesthesia analgesia and stress levels, and reliable monitoring of responses to noxious stimulation. During tracheal intubation for general anesthesia, when the qCON value falls within the range of 40 to 60 and the qNOX value is between 30 and 50, it indicates that the patient is in an appropriate state of sedation and analgesia. However, there is currently no universally acknowledged standard for the optimal qNOX reference range during conscious sedation endoscopy. Therefore, this study utilizes the noxious stimulation response index (qNOX) to monitor noxious stimulation during the procedure, aiming to identify the best timing for inserting the endoscope during conscious sedation endoscopy and explore the appropriate range of qNOX for this purpose.

Anesthesia Induction Scheme for Painless Gastrointestinal Endoscopy Patients Based on Nociceptive Stimulation Monitoring

Nociception is the encoding and processing of noxious stimulation and is considered an objective indicator for monitoring pain. Currently, a new clinically-applied medical-engineering integrated monitoring device for noxious stimulation response has emerged. Its fundamental principle is based on the monitoring of electroencephalographic (EEG) activity, incorporating two monitoring parameters: the quantitative consciousness (qCON) index and the quantitative nociceptive (qNOX) index. However, in the context of sedation for gastrointestinal endoscopy, how the dynamic changes of the quantitative consciousness index (qCON) and the quantitative nociception index (qNOX) reflect the depth of sedation and nociceptive response remains unclear. Safe and effective sedation monitoring includes both direct visual monitoring and physiological monitoring, that is, monitoring the patient's hemodynamics and depth of sedation. This study utilizes qCON and qNOX monitoring to assess the sedation and analgesic states of patients undergoing painless gastroenterological endoscopy. By combining visual assessment (cough reflex, respiratory depression, and limb movement) with clinical physiological monitoring (vital signs monitoring and pulse oximetry), the aim is to explore the optimal sedation range for gastrointestinal endoscopy under sedation, providing new anesthesia monitoring tools for clinical use.