Patients undergoing major abdominal surgery
Conditions
Interventions
MAP-PeriFormer Guided Management Group:In this group, the MAP-PeriFormer model will provide an alert to the anesthesiologist when it predicts a high probability of hypotension occurring within a speci
Routine management group:Patients in this group were managed according to standard clinical practice. Although the MAP-PeriFormer was still available in the control group, anesthesiologists did not re
Sponsors
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 65 years; 2. Patients scheduled for elective gastrointestinal surgery, with an estimated operative duration >= 2 hours and an expected hospital stay >= 3 days; 3. Patients with unimpaired communication ability, a Mini-Mental State Examination (MMSE) score >= 24, and the capability to comply with all protocols during the trial; 4. Agreement to participate in this study and provision of signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Refusal to participate in the study; 2. History of chronic alcoholism or substance/drug dependence; 3. Preoperative severe cognitive dysfunction, defined as a Mini-Mental State Examination (MMSE) score of 133 µmol/L, or ongoing renal replacement therapy (dialysis); 5. History of cerebrovascular accident, myocardial infarction, or unstable angina within the past 3 months; 6. Known severe liver cirrhosis, or preoperative laboratory tests indicating Child-Pugh class B or higher; 7. Pre-existing neurological disorders, including: dementia, Parkinson's disease, history of stroke with associated cognitive impairment, or long-term use of antipsychotic medications. 8. Having undergone any surgery within the past 3 months, or participation in any other interventional clinical trial within the past 30 days; 9. Pre-existing severe bradycardia (e.g., sick sinus syndrome, high-grade atrioventricular block without a pacemaker) or severe arrhythmia that is anticipated to require frequent intervention during surgery; 10. Preoperative severe hemodynamic instability, for instance, requiring high-dose vasopressor support (e.g., norepinephrine > 0.1 µg/kg/min) to maintain blood pressure due to conditions such as sepsis or active bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time-weighted average (TWA) of intraoperative hypotension, defined as the area under the curve (AUC) of mean arterial pressure (MAP) less than 65 mmHg over the duration of surgery.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative delirium;Acute kidney injury;Myocardial injury after non cardiac surgery, MINS;Incidence of postoperative delirium;Adverse event;Severity of postoperative POD;Incidence of PONV within 48 hours after surgery;Severity of postoperative nausea and vomiting; | — |
Countries
China
Contacts
Public ContactXiaoping Gu
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Outcome results
None listed