BRAIN-targeted Goal-directed Therapy in High-risk Patients undeRgOing Major electIve SurgEry: the BRAIN-PROMISE Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Surgery
- Sponsor
- Istituto Clinico Humanitas
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Percentage of successful reversal of reduction in NIRS, according to the hemodynamic optimization protocol.
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Detailed Description
Background: Perioperative complications lead to impaired quality of life as well as prolonged disability. In high risk patients, early hemodynamic optimization with the goal of achieving and maintaining tissue oxygenation in the perioperative period has resulted in an improvement of outcomes and a reduction in surgery-related complications. Maintenance of adequate oxygen delivery to tissue, is one of the fundamental aspects of anesthesia. Regional Oxygen Saturation of the brain tissue (rSO2) as measured by near-infrared spectroscopy (NIRS) is a promising tool in vascular surgery and cardiac surgery for the monitoring of global cerebral perfusion. Objectives: This study has the purpose to assess whether an rSO2-based hemodynamic optimization algorithm is able to reduce overall perioperative complications in high risk patients. Design: BRAIN-PROMISE is a monocentric, randomized controlled trial. Population: Hypertensive elderly or frail patients undergoing major surgery. Experimental Intervention: Cases will be managed using a NIRS-targeted goal directed therapy. Control Intervention: Controls will be managed according to standard care. Outcomes: The primary outcome are the incidence of perioperative complications at 30 days and the percentage of successful reversal of reduction in NIRS. Trial size: A total of 200 patients will be randomized.
Investigators
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.
Outcomes
Primary Outcomes
Percentage of successful reversal of reduction in NIRS, according to the hemodynamic optimization protocol.
Time Frame: intraoperative
The overall incidence of perioperative complications (including postoperative cognitive dysfunction and delirium).
Time Frame: 30 day after randomization
Secondary Outcomes
- Percentage of time with NIRS within safety limits (<10% reduction)(intraoperative)
- NIRS variations over time, and according to interventions(intraoperative)
- Bispectral index (BIS) over time(intraoperative)
- sevorane concentration over time(intraoperative)
- Evaluate fluid administration(intraoperative)
- Mean arterial pressure (MAP) over time(intraoperative)
- Use of vasopressors and fluids to maintain MAP(intraoperative)