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

Launched by ISTITUTO CLINICO HUMANITAS · Feb 11, 2020

Keywords

ClinConnect Summary

The BRAIN-PROMISE Study is a clinical trial aiming to explore whether using a special monitoring technique called Near Infrared Spectroscopy (NIRS) can help reduce complications after surgery in patients who are considered high-risk. This study focuses on patients aged 65 and older or those with certain health conditions who are undergoing major elective surgeries, such as abdominal, vascular, or thoracic procedures that require general anesthesia and last longer than 60 minutes.

To be eligible for the trial, participants need to have high blood pressure and meet specific health criteria, like having a certain score on a frailty scale or an American Society of Anesthesiologists (ASA) score of 2 or higher. They must also have an arterial catheter placed during anesthesia. If you or a loved one are interested in participating, you should be able to understand the study and give consent. However, individuals with severe neurological disorders, certain psychiatric conditions, or those who cannot provide consent will not be included. Participants will be monitored closely throughout the surgical process, and this study hopes to find ways to improve recovery and outcomes for those at higher risk.

Gender

ALL

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.