Actively Recruiting

All Genders
ID07253012

AI-assisted Analgesia Copilot System for Proper Management of Nociception

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

150

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new AI-assisted co-pilot system called SEASCAPE to improve pain management during general anesthesia. This system uses machine learning to monitor and control nociception—the nervous system's response to pain—by analyzing real-time physiological data from multiple monitors. The goal is to optimize the dosing of intravenous opioids like remifentanil to reduce both over- and under-dosing, potentially improving patient outcomes and reducing opioid-related complications during surgery. The study involves patients scheduled for elective surgeries requiring general anesthesia, where standard analgesia is provided by continuous remifentanil infusion controlled by a pharmacokinetic/pharmacodynamic model. SEASCAPE integrates this existing model with real-time data from monitors tracking hemodynamics, EEG, neuromuscular relaxation, and analgesia indices to provide personalized dosing recommendations. The project is conducted in three phases: initial data collection from 30 patients, expanded data collection from 100 patients under different anesthetic techniques, and usability assessment involving 20 anesthesiologists using the system in pilot mode. Participants will undergo general anesthesia with standard care while data is collected from multiple devices connected via a digital platform. The system will classify nociception levels and suggest adjustments to opioid dosing without altering usual clinical decisions. Researchers will analyze physiological patterns, anesthetic depth, muscle relaxation, and clinician feedback to assess the system's accuracy and usability. The entire process spans from the start to the end of anesthesia, aiming to refine intraoperative pain control and improve postoperative outcomes.

CONDITIONS

Brief 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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - From the beginning of the anesthetic process to the end of anesthesia

Participants are observed during surgery under general anesthesia while multiple physiological and pharmacological data are collected using monitoring devices and the SEASCAPE AI-assisted copilot system to assess nociception and anesthetic management.

1 surgical procedure visit (in-person)

Clinical Usability Assessment

Duration - During the anesthetic process and system use

Anesthesiologists use the SEASCAPE interface to provide feedback on usability, strengths, and opportunities for improvement of the system.

1 assessment session (in-person)

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

K

Karen Azagra, RA

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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Published Research Related To This Trial