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RECRUITING
NCT07253012

AI-Assisted Analgesia Copilot System

Sponsor: Pontificia Universidad Catolica de Chile

View on ClinicalTrials.gov

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.

Official title: AI-assisted Analgesia Copilot System for Proper Management of Nociception

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2026-01-29

Completion Date

2027-10-27

Last Updated

2026-03-09

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Hemodynamic monitor, BIS, TOF, ANI, anesthesia machine and infusion pumps

Extraction of data obtained from hemodynamic monitoring, BIS, ANI, anesthesia machine and infusion pumps using Mindray's e-getaway system.

DEVICE

SEASCAPE

Artificial intelligence-assisted copilot system for nociception management. SEASCAPE First generation.

Locations (2)

Division de Anestesiologia

Santiago, Chile

Hospital Clinico UC Christus

Santiago, Chile