AI-assisted analgesia copilot to guide remifentanil dosing during general anesthesia
AI-assisted Analgesia Copilot System for Proper Management of Nociception
This project will test an AI 'co-pilot' that monitors multiple physiological signals during general anesthesia to guide remifentanil dosing and reduce over- or under-dosing for adults having elective surgeries of 2–4 hours.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Sex | All |
| Sponsor | Pontificia Universidad Catolica de Chile Academic / other |
| Locations | 2 sites (Santiago and 1 other locations) |
| Trial ID | NCT07253012 on ClinicalTrials.gov |
What this trial studies
This observational project develops and applies a machine-learning/AI co-pilot that integrates data from hemodynamic monitors, BIS, TOF, ANI, anesthesia machines, and infusion pumps to monitor nociception in real time. The system aims to distinguish genuine nociceptive responses from confounding physiological signals and to support precise titration of remifentanil using target-controlled infusion. Data will be captured during elective general anesthesia cases lasting between two and four hours to train and validate the algorithm in a clinical operating-room environment. The intent is to create a clinical implementation tool that can provide actionable, real-time guidance for individualized opioid dosing.
Who should consider this trial
Good fit: Adults scheduled for elective surgery under general anesthesia expected to last between two and four hours are the intended participants.
Not a fit: Patients undergoing emergency surgery, pregnant patients, those with pre-existing mental or intellectual disability, drug dependence, surgeries shorter than two hours or longer than four hours, or cases with major intraoperative complications are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could enable more precise remifentanil dosing during surgery, lowering opioid-related complications and improving recovery and cost-effectiveness.
How similar studies have performed: Prior work using nociception indices and PK/PD models has shown promise, but fully integrated AI co-pilot systems for intraoperative opioid titration remain largely unproven in routine clinical practice.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Santiago and 1 other locations
- Division de Anestesiologia — Santiago, Chile (Not_yet_recruiting)
- Hospital Clinico UC Christus — Santiago, Chile (Recruiting)
Study contacts
- Principal investigator: Victor Contreras, RN, MSN — Pontificia Universidad Catolica de Chile
- Study coordinator: Victor Contreras, RN, MSN
- Email: vecontre@uc.cl
- Phone: +56955049217
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.