NCT04266574 BRAIN-targeted Goal-directed Therapy in High-risk Patients undeRgOing Major electIve SurgEry: the BRAIN-PROMISE Study
| NCT ID | NCT04266574 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Clinico Humanitas |
| Condition | Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2020-11-17 |
| Primary Completion | 2024-12 |
Trial Parameters
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Brief Summary
The aim of the study is to further understand whether the use of non-invasive monitoring NIRS (Near Infrared Spectroscopy) is useful in reducing postoperative complications in high-risk patients undergoing elective surgery.
Eligibility Criteria
Inclusion Criteria: * hypertensive patients with American Society of Anesthesiologists (ASA) score≥ 2 with either Age ≥ 65 years or frailty score ≥5 * presence of an arterial catheter during anesthesia * planned high-risk surgery (abdominal, vascular, urologic, thoracic one-lung ventilation (OLV) procedures), longer than 60 minutes, in general anesthesia * ability to give informed consent according to International Conference on Harmonization ICH/ Good Clinical Practice (GCP), and national/local regulations Exclusion Criteria: * Unable to consent to study inclusion * Language barrier * Severe neurological or psychiatric disease * End-stage dementia * Total Intravenous anesthesia * No use of hypertensive medication at home.