AI-Assisted Blood Pressure Control During Anesthesia

NCT07123675 | Not Yet Recruiting

• 1 other identifier: 24444-4-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This study is being done to see if a new computer-based tool can help anesthesiologists keep patients' anesthesia levels more stable during surgery. 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.

Conditions

General Anesthesia

Keywords

Reinforcement Learning; Artificial Intelligence; Clinical Decision Support System; Depth of Anesthesia

Outcome Measures

Primary Outcomes (1)

• Mean Arterial Pressure Time in Range (MAP TIR)

  The percentage of time that the patient's Mean Arterial Pressure (MAP) is maintained within a pre-defined target range (e.g., 65-75 mmHg) during the surgical procedure. A higher percentage indicates more effective and stable blood pressure control.

  From the induction of anesthesia until the end of the surgical procedure.

Secondary Outcomes (4)

• Variability of Mean Arterial Pressure (MAP)

  From the induction of anesthesia until the end of the surgical procedure.

• Total Consumption of Propofol

  From the induction of anesthesia until the end of the surgical procedure.

• Total Consumption of Remifentanil

  From the induction of anesthesia until the end of the surgical procedure.

• Incidence of Intraoperative Adverse Events

  From the induction of anesthesia until the end of the surgical procedure.

Study Arms (2)

Experimental: AI-Assisted Anesthesia Management

EXPERIMENTAL

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: Device: AI Clinical Decision Support System

Active Comparator: Standard Anesthesia Care

ACTIVE COMPARATOR

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: Procedure: Standard of Care Anesthesia

Interventions

Device: AI Clinical Decision Support System DEVICE

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

Experimental: AI-Assisted Anesthesia Management

Procedure: Standard of Care Anesthesia PROCEDURE

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.

Active Comparator: Standard Anesthesia Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age range: 18 to 85 years. 2. Patients undergoing non-cardiac surgery. 3. Receiving intravenous-inhalation combined general anesthesia with tracheal intubation during surgery.
• \. Patients undergoing elective surgery. 5. Anesthesia maintenance plan includes:
• Propofol for continuous sedation during the maintenance phase;
• Remifentanil for continuous analgesia during the maintenance phase;
• 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.
• \. Continuous invasive arterial blood pressure monitoring during surgery.

You may not qualify if:

• \. Emergency surgery. 2. Continuous infusion of remifentanil or propofol for less than 30 minutes during surgery.
• \. Receiving continuous intravenous sedatives other than propofol, or continuous infusion of intravenous sedatives other than propofol.
• \. Receiving continuous intravenous analgesics other than remifentanil, or continuous infusion of intravenous analgesics other than remifentanil.
• \. Inhaled anesthetic maintenance concentration is not equal to 0.5 Minimum Alveolar Concentration (MAC).
• \. Allergy to propofol or allergic reaction to remifentanil. 7. Severe obesity (BMI ≥ 35 kg/m²).

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead
• Peking University People's Hospital: collaborator

Study Sites (2)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

Location

Central Study Contacts

Gao Zhifeng, MD

CONTACT

15801249466; btchgzf@hotmail.com

Zheng Zhang, MD

CONTACT

18801238359; 18756235568@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The care provider (anesthesiologist) is not masked to the intervention, as they must be able to view and interact with the clinical decision support system in the experimental arm. The patient and the outcomes assessor will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Anesthesiology

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 14, 2025
• Study Start: September 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 15, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)