| NCT ID | NCT07253012 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pontificia Universidad Catolica de Chile |
| Condition | Nociception |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-01-29 |
| Primary Completion | 2026-10-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2026-01-29 with a primary completion date of 2026-10-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Patients scheduled for elective surgery with general anesthesia. * Surgeries scheduled to last at least two hours. Exclusion Criteria: * Patients undergoing emergency surgery. * Pregnant women. * Presence of a mental or intellectual disability before the hospitalization. * Drug dependence. * Surgeries scheduled for more than 4 hours. * Intraoperative complications requiring changes in routine behavior.
Contact & Investigator
Victor Contreras, RN, MSN
PRINCIPAL INVESTIGATOR
Pontificia Universidad Catolica de Chile
Frequently Asked Questions
Who can join the NCT07253012 clinical trial?
This trial is open to participants of all sexes, studying Nociception. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07253012 currently recruiting?
Yes, NCT07253012 is actively recruiting participants. Contact the research team at vecontre@uc.cl for enrollment information.
Where is the NCT07253012 trial being conducted?
This trial is being conducted at Santiago, Chile, Santiago, Chile.
Who is sponsoring the NCT07253012 clinical trial?
NCT07253012 is sponsored by Pontificia Universidad Catolica de Chile. The principal investigator is Victor Contreras, RN, MSN at Pontificia Universidad Catolica de Chile. The trial plans to enroll 150 participants.