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

NCT07713121 · tracked via the Priya Life Science Germany tracker

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Phase

Not applicable

Started

2026-08-21

Last updated

2026-08-25

Condition(s) studied

Postoperative Delirium (POD)Intraoperative Hypotension

Investigational drug(s) / intervention(s)

MAP at 85 mmHg or higher (intervention group)MAP at 65 mmHg or higher (control group)

MAP at 85 mmHg or higher (intervention group): 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): 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.

Study summary

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.

Eligibility

Sex

ALL

Min age

65 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Delirium within the first 3 postoperative days (binary outcome) — within the first 3 postoperative days
Delirium will be assessed on the day of surgery after transfer from the post-anesthesia care unit to the general ward or intensive care unit and twice daily on postoperative days 1, 2, and 3. The 3-Minute Diagnostic Confusion Assessment Method will be used for patients on general wards and the Confusion Assessment Method for the Intensive Care Unit for patients in intensive care units.

Trial sites (1)

Facility	City	Region	Status
• Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Hamburg	Hamburg	Germany	Recruiting

More Universitätsklinikum Hamburg-Eppendorf trials in Germany

External Validation of the MASCAN Score for the Classification of Difficult Mask Ventilation Recruiting

Characterisation of phenotYpes in aCute Heart faiLure patiEnts Recruiting

Prospective Registry and Biobank for Long-term Observational Studies in Adult Patients with Pulmonary Hypertension Recruiting

Proof of Concept Human Study: Dietary Intervention to Modify Intestinal Inflammation in IBD Active, not recruiting

Cerebellar Transcranial Alternating Current Stimulation (tACS) to Modulate Parkinson's Disease Tremor Recruiting

Other trials for the same condition

Oscillometric Versus Intraarterial Blood Pressure Monitoring During Robot-Assisted Prostatectomy Recruiting

Non-invasive Measurement of the Hypotension Prediction Index for the Reduction of Intraoperative Hypotension Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07713121 on ClinicalTrials.gov ↗ ← All trials in Germany