Actively Recruiting

All Genders
NCT07253012

AI-Assisted Analgesia Copilot System

Led by Pontificia Universidad Catolica de Chile · Updated on 2026-03-09

150

Participants Needed

2

Research Sites

90 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

AI-Assisted Analgesia Copilot System

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled for elective surgery with general anesthesia.
  • Surgeries scheduled to last at least two hours.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Division de Anestesiologia

Santiago, Chile

Not Yet Recruiting

2

Hospital Clinico UC Christus

Santiago, Chile

Actively Recruiting

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Research Team

V

Victor Contreras, RN, MSN

CONTACT

K

Karen Azagra, RA

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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