BRAIN-targeted Goal-directed Therapy in High-risk Patients undeRgOing Major electIve SurgEry: the BRAIN-PROMISE Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituto Clinico Humanitas

About this trial

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

Qualifiers

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

Disqualifiers

Unable to consent to study inclusion

Language barrier

Severe neurological or psychiatric disease

End-stage dementia

Trial design

Treatments tested in this trial

  • Near Infrared Spectroscopy (NIRS)
  • Standard Care

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators