About this trial
The goal of this clinical trial is to learn if using artificial intelligence to guide intravenous fluid therapy during major cancer surgery can help keep blood pressure more stable compared with usual care in adult patients undergoing major cancer surgery. The main questions it aims to answer are:
* Does artificial intelligence-guided fluid therapy reduce hypotensive events during surgery? * Does this approach improve recovery and reduce complications after major cancer surgery?
Researchers will compare artificial intelligence-guided fluid therapy with standard fluid management to see if the artificial intelligence-guided approach provides better support during surgery.
Participants will:
* Undergo major cancer surgery under general anesthesia * Receive either artificial intelligence-guided fluid management or standard fluid management during surgery * Be monitored during and after surgery as part of routine clinical care * Be followed after surgery to assess recovery and possible complications
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
American Society of Anesthesiologists (ASA) Physical Status II-IV
Undergoing major abdominal oncologic surgery (open or laparoscopic) with an expected duration >2 hours
Planned invasive arterial pressure monitoring
Disqualifiers
Significant arrhythmias (e.g., persistent atrial fibrillation)
Severe aortic stenosis
Emergency surgery
Sepsis
Trial design
Parallel
Treatments tested in this trial
Artificial Intelligence-Assisted Fluid Management
Other interventionIn this intervention, intraoperative intravenous fluid management is supported by an artificial intelligence-based clinical decision support system. The system continuously analyzes real-time hemodynamic data derived from standard intraoperative monitoring and provides recommendations for intravenous fluid administration. Clinicians are strongly encouraged to follow these recommendations but retain full responsibility and may accept or override them based on clinical judgment. The intervention is applied during the intraoperative period only and does not replace standard anesthetic care.
Standard fluid management
Other interventionIn this intervention participants receive intraoperative intravenous fluid therapy managed according to usual clinical practice, without artificial intelligence guidance. Fluid administration is determined by the attending clinician based on standard monitoring and clinical judgment.
Treatment groups
Trial outcomes
Primary outcomes
Intraoperative Hypotension Burden
The burden of intraoperative hypotension, measured as the time-weighted average (TWA) of intraoperative hypotension, a composite measure that accounts for both the depth and duration of low arterial blood pressure over time. TWA reflects the overall hypotensive burden during surgery by integrating how low blood pressure falls and for how long it remains below predefined thresholds, assessed using continuous invasive blood pressure monitoring
Sponsors and contacts
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