Comparison of Artificial Intelligence and Anesthesiologist in Preoperative Risk Assessment (AI-PREOP)

January 18, 2026 updated by: Gülgün Elif Aksoy

Clinical Performance of a Machine Learning-Based Artificial Intelligence System Compared With Anesthesiologist Assessment in Preoperative Patient Evaluation

Preoperative evaluation is essential for identifying patient-related risks before elective surgery and for planning safe anesthesia management. Traditionally, this evaluation is performed by anesthesiologists based on clinical history, physical examination, comorbidities, and laboratory findings.

This observational study aims to compare the clinical performance of a machine learning-based artificial intelligence system with anesthesiologist assessment during preoperative patient evaluation. The artificial intelligence system independently analyzes patient data and generates risk assessments, which are then compared with evaluations performed by anesthesiologists.

The primary objective of the study is to assess the level of agreement between the artificial intelligence system and anesthesiologists in preoperative risk assessment. Secondary objectives include evaluating the accuracy and consistency of the artificial intelligence system and exploring its potential role as a decision-support tool in preoperative clinical practice.

The findings of this study may contribute to understanding the potential benefits and limitations of artificial intelligence-assisted decision making in preoperative evaluation

Study Overview

Status

Completed

Detailed Description

Preoperative evaluation is a critical component of perioperative care, aimed at identifying patient-specific risks, optimizing patient safety, and guiding anesthetic planning prior to elective surgical procedures. This process traditionally relies on the clinical judgment of anesthesiologists, who integrate medical history, physical examination findings, comorbid conditions, and relevant laboratory data to assess perioperative risk.

Recent advances in artificial intelligence and machine learning have enabled the development of clinical decision-support systems capable of analyzing complex clinical data and generating predictive risk assessments. Despite increasing interest in these technologies, their clinical performance and reliability in real-world preoperative settings remain insufficiently evaluated.

This observational study is designed to compare preoperative risk assessments generated by a machine learning-based artificial intelligence system with routine anesthesiologist-led evaluations. Adult patients scheduled for elective surgery will undergo standard preoperative assessment performed by anesthesiologists as part of usual clinical care. Independently, anonymized patient data will be processed by the artificial intelligence system to produce preoperative risk assessments. The artificial intelligence output will not be available to clinicians and will not influence patient management.

The primary outcome of the study is the level of agreement between the artificial intelligence system and anesthesiologists in preoperative risk stratification. Secondary outcomes include the consistency, concordance, and overall performance of artificial intelligence-generated assessments compared with clinician evaluations.

This study involves no interventions and does not alter standard patient care. All anesthetic and perioperative management decisions will remain entirely under the responsibility of the treating anesthesiologist. By systematically comparing artificial intelligence-based assessments with clinician evaluations, this study aims to clarify the potential role, strengths, and limitations of artificial intelligence as a supportive tool in routine preoperative evaluation

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Trabzon
      • Trabzon, Trabzon, Turkey (Türkiye)
        • Trabzon Faculty of Medicine, Kanuni Training and Research Hospital,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult patients aged 18 years and older who were scheduled for elective surgical procedures and underwent routine preoperative evaluation at a tertiary care university hospital. Preoperative risk assessments performed by anesthesiologists were compared with artificial intelligence-based risk assessments using the same clinical data.

Description

Inclusion Criteria:

  • - Adult patients aged 18 years and older
  • Patients scheduled for elective surgery under anesthesia
  • Patients who underwent routine preoperative evaluation
  • Availability of complete preoperative clinical data required for both anesthesiologist and artificial intelligence-based assessment

Exclusion Criteria:

  • - Patients younger than 18 years
  • Emergency surgery cases
  • Patients with incomplete or missing preoperative clinical data
  • Patients who declined participation or whose data could not be evaluated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Agreement Between Artificial Intelligence-Based and Anesthesiologist Preoperative Risk Assessments
Time Frame: At the time of preoperative evaluation
This outcome measures the level of agreement between an artificial intelligence-based preoperative evaluation system and anesthesiologist assessment, including American Society of Anesthesiologists (ASA) physical status classification and overall perioperative risk stratification. Agreement will be evaluated using appropriate statistical measures.
At the time of preoperative evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gülgün E Aksoy, MD, Trabzon Faculty of Medicine, Kanuni Training and Research Hospital, Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Actual)

May 1, 2025

Study Completion (Actual)

October 30, 2025

Study Registration Dates

First Submitted

January 10, 2026

First Submitted That Met QC Criteria

January 18, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 18, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • PREOP-AI-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared. The study has been completed, and no prospectively defined plan for data sharing was included in the study protocol or the ethics committee approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe