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RECRUITING Not applicable ClinicalTrials.gov

Maintaining Intraoperative Mean Arterial Pressure at 85 mmHg or Higher to Reduce Postoperative Delirium in Older Patients With Arterial Hypertension Having Non-cardiac Surgery

Sponsor: Universitätsklinikum Hamburg-Eppendorf • ClinicalTrials.gov ID: NCT07713121

Registry updated: 2026-08-25
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Description

In older patients having surgery, postoperative delirium (an acute disturbance in awareness, attention, or cognition) is common and associated with short-term and long-term morbidity and mortality. The pathophysiology of postoperative delirium is multifactorial - but presumably includes inadequate brain perfusion during surgery caused by low intraoperative blood pressure. Therefore, the investigators aim to determine in a multicenter randomized-controlled trial if targeted intraoperative blood pressure management reduces postoperative delirium. The investigators will test the primary hypothesis that maintaining intraoperative mean arterial pressure at 85 mmHg or higher - compared to at 65 mmHg or higher (routine care) - reduces the incidence of postoperative delirium within the first 3 postoperative days in older patients with arterial hypertension having non-cardiac surgery. The investigators will also assess the duration of postoperative delirium, postoperative complications, and the patients' quality of life. The results of this trial will have a direct impact on guidelines and will help improve medical care for patients and the patients' health. Effective strategies to prevent postoperative delirium are missing. The hypothesis that targeted intraoperative blood pressure management can help reduce postoperative delirium is supported by previous observational studies and interventional trials. This trial is supposed to confirm the causal relationship between intraoperative blood pressure and postoperative delirium and to demonstrate the effectiveness of the therapeutic approach.

Interventions

  • MAP at 85 mmHg or higher (intervention group) (Other)
    In patients assigned to the intervention group, clinicians will be instructed to maintain MAP at 85 mmHg or higher. The trial intervention will start at the beginning of induction of general anesthesia and ends at the end of surgery.
  • MAP at 65 mmHg or higher (control group) (Other)
    In patients assigned to the control group, clinicians will be instructed to maintain MAP at 65 mmHg or higher. The trial intervention will start at the beginning of induction of general anesthesia and ends at the end of surgery.

Eligibility criteria

Inclusion Criteria: To be eligible for trial inclusion, patients must: * 1\) be able to provide informed consent, AND * 2\) be ≥65 years old, AND * 3\) be scheduled for elective non-cardiac surgery with general anesthesia that is expected to last ≥120 minutes, AND * 4\) have chronic arterial hypertension requiring antihypertensive medication OR have a systolic arterial pressure ≥140 mmHg or diastolic arterial pressure ≥90 mmHg on a measurement performed within the previous year, AND * 5\) be at high risk for postoperative delirium because: American Society of Anesthesiologists physical status class III or IV OR Charlson Comorbidity Index ≥3 points (please see Appendix 1) OR frailty (documented in medical records or clinical diagnosis) Exclusion Criteria: Patients that meet one or more of the following exclusion criteria cannot participate in the trial: * solid organ transplant surgery * intracranial surgery * surgery in sitting position * sepsis * surgery in the previous 30 days * previous participation in ASPIRE-85

Conditions

Postoperative Delirium (POD) Intraoperative Hypotension

Locations

  • • Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg — Hamburg, Germany
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record