Actively Recruiting
BRAIN-targeted Goal-directed Therapy in High-risk Patients undeRgOing Major electIve SurgEry: the BRAIN-PROMISE Study
Led by Istituto Clinico Humanitas · Updated on 2024-10-23
200
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
BRAIN-targeted Goal-directed Therapy in High-risk Patients undeRgOing Major electIve SurgEry: the BRAIN-PROMISE Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hypertensive patients with American Society of Anesthesiologists (ASA) score 2 2 and either age 2 65 years or frailty score 2 5
- Presence of an arterial catheter during anesthesia
- Planned high-risk surgery (abdominal, vascular, urologic, thoracic one-lung ventilation procedures) lasting longer than 60 minutes under general anesthesia
- Ability to give informed consent according to International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) and national/local regulations
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Humanitas Research Hospital
Rozzano, Milan, Italy, 20089
Actively Recruiting
Research Team
M
Maurizio Cecconi, Prof, MD
CONTACT
M
Massimiliano Greco, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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