PROtocolized care to reduce HYpotension after spinal anaesthesia (ProCRHYSA randomized trial): Study protocol for a...

Area of Science:

• Anesthesiology
• Critical Care Medicine
• Surgical Patient Management

Background:

• The PROtocolized Care to Reduce HYpotension after Spinal Anaesthesia (ProCRHYSA) trial is a randomized study evaluating controlled fluid repletion.
• Post-spinal anesthesia hypotension is a common complication, impacting patient safety and surgical outcomes.
• The trial is registered on ClinicalTrials.gov (NCT02070276).

Purpose of the Study:

• To assess the effectiveness of non-invasive tests in guiding fluid administration before spinal anesthesia.
• To reduce the rate of clinically significant hypotension following spinal anesthesia.
• To minimize the total amount of fluid administered, avoiding both hypotension and fluid overload.

Main Methods:

• A randomized, parallel-group trial involving patients undergoing elective surgery under spinal anesthesia.
• Group 1: Vena cava ultrasound to guide crystalloid bolus administration based on volemic status.
• Group 2: Passive leg raising test to guide crystalloid bolus administration.

Main Results:

• The study hypothesizes that these non-invasive methods will reduce hypotension compared to empirical fluid administration.
• The primary outcome is the rate of clinically significant hypotension.
• Secondary outcomes include the total fluid volume administered.

Conclusions:

• Vena cava ultrasound and passive leg raising tests show promise as screening tools for preventing post-spinal anesthesia hypotension.
• This is the first application of these validated critical care tests in an elective surgical population.
• The findings aim to enhance the safety of spinal anesthesia through optimized fluid management.