Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-09-01
2025-12-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Background: During general anesthesia, doctors carefully adjust medication doses to keep patients safely and comfortably unconscious. This requires constant attention. Researchers want to find out if a smart computer assistant can help with this task.
Purpose of the Study: The main goal is to compare two ways of managing anesthesia. One way is the standard method used by doctors today. The other way is having the doctor use suggestions from a new computer program designed to recommend medication doses in real-time. We want to see if using the computer tool can lead to more stable anesthesia, potentially using less medication and helping patients recover more smoothly.
Who Can Participate: The study will include adult patients who are scheduled to have surgery that requires general anesthesia.
What Will Happen in the Study: If you choose to join, you will be randomly assigned (like flipping a coin) to one of two groups:
Standard Care Group: Your anesthesiologist will manage your anesthesia medications based on their expert judgment and normal practice, as is done every day.
Computer-Assisted Group: Your anesthesiologist will also manage your anesthesia, but they will see suggestions from a computer system on a screen. The doctor will always have the final say and can choose to follow or ignore the computer's advice to ensure your safety.
In both groups, you will receive safe and complete anesthetic care. Your participation in the study will last for the duration of your surgery and the immediate recovery period. Researchers will look at information like the amount of medication used and how stable your anesthesia level was.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dual-loop Target Controlled Infusion for Coadministration of Propofol and Remifentanil Guided by Narcotrend Index
NCT02890186
Decision Support System for Anesthetists
NCT04079036
Machine Learning-Based Model for Individualized Drug Dose Prediction for Propofol
NCT06703879
THe Comparison of Target Controlled Infusion of Propofol or Etomidate at General Anesthesia in Geriatric Patients
NCT02111265
Anesthesia Induction with the Target-controlled Infusion of Propofol in High-risk Patients
NCT06535230
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Hypothesis: The use of an RL-based decision support system for guiding anesthetic drug administration results in a greater percentage of time within a target range of anesthetic depth compared to standard manual practice by anesthesiologists.
Study Design: This is a prospective, dual-center, parallel-group, randomized controlled superiority trial.
Objectives:
Primary Objective: To compare the percentage of case time that the Bispectral Index (BIS) is maintained within the target range of 40 to 60 between the RL-guided group and the standard care group.
Secondary Objectives: To compare total consumption of anesthetic agents (e.g., propofol and remifentanil), incidence and duration of intraoperative hypotension, time to tracheal extubation, and length of stay in the post-anesthesia care unit (PACU).
Interventions:
Intervention Group (RL-Guided): Anesthesiologists will manage general anesthesia with the aid of a real-time decision support system. The system, powered by a reinforcement learning algorithm, will display continuous dosing recommendations for propofol and remifentanil. The attending anesthesiologist retains full clinical autonomy and is responsible for all final dosing decisions.
Control Group (Standard Care): Anesthesiologists will manage general anesthesia according to their clinical experience and institutional standard of care, without input from the decision support system.
Study Population: Adult patients (aged 18-65 years), ASA physical status I-III, scheduled for elective surgery expected to last at least two hours under general anesthesia. Key exclusion criteria include known allergies to anesthetic agents, severe cardiovascular or respiratory disease, and emergency surgery.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental: AI-Assisted Anesthesia Management
Participants in this arm will have their general anesthesia managed by an anesthesiologist with real-time guidance from an AI-based clinical decision support system. The system provides recommendations for drug administration and physiological parameter adjustments.
Device: AI Clinical Decision Support System
An AI-based software system that provides real-time, on-screen recommendations to the anesthesiologist regarding drug administration and adjustments to maintain optimal patient physiological parameter
Active Comparator: Standard Anesthesia Care
Participants in this arm will receive standard-of-care general anesthesia management. The anesthesiologist will make all clinical decisions based on their professional judgment and standard institutional practices, without the aid of the investigational AI system.
Procedure: Standard of Care Anesthesia
Standard anesthesia management according to institutional guidelines. The attending anesthesiologist makes all clinical decisions based on their expertise and judgment without input from the investigational AI system.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Device: AI Clinical Decision Support System
An AI-based software system that provides real-time, on-screen recommendations to the anesthesiologist regarding drug administration and adjustments to maintain optimal patient physiological parameter
Procedure: Standard of Care Anesthesia
Standard anesthesia management according to institutional guidelines. The attending anesthesiologist makes all clinical decisions based on their expertise and judgment without input from the investigational AI system.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
4\. Patients undergoing elective surgery. 5. Anesthesia maintenance plan includes:
1. Propofol for continuous sedation during the maintenance phase;
2. Remifentanil for continuous analgesia during the maintenance phase;
3. Sevoflurane or desflurane for inhalation anesthesia. 6. ASA physical status I-IV. 7. Continuous monitoring of blood pressure, heart rate, and Bispectral Index (BIS) during surgery.
8\. Continuous invasive arterial blood pressure monitoring during surgery.
Exclusion Criteria
3\. Receiving continuous intravenous sedatives other than propofol, or continuous infusion of intravenous sedatives other than propofol.
4\. Receiving continuous intravenous analgesics other than remifentanil, or continuous infusion of intravenous analgesics other than remifentanil.
5\. Inhaled anesthetic maintenance concentration is not equal to 0.5 Minimum Alveolar Concentration (MAC).
6\. Allergy to propofol or allergic reaction to remifentanil. 7. Severe obesity (BMI ≥ 35 kg/m²).
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peking University People's Hospital
OTHER
Beijing Tsinghua Chang Gung Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhifeng Gao
Professor, Department of Anesthesiology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking University People's Hospital
Beijing, Beijing Municipality, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
24444-4-03
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.