Effects of remimazolam versus propofol on cerebral oxygenation in elderly patients undergoing prone spine surgery: study protocol for a randomised controlled trial.

In 30 seconds

This article describes the protocol for a prospective, single-centre randomised controlled trial comparing remimazolam with propofol-based total intravenous anaesthesia in elderly patients undergoing elective thoracic or lumbar spine surgery in the prone position. Sixty patients are planned for 1:1 allocation. The primary outcome is the between-group difference in the time-weighted average change in regional cerebral oxygen saturation, measured by near-infrared spectroscopy, from supine baseline to the prone position. Secondary outcomes include cerebral desaturation, haemodynamic measures, vasopressor use, complications and postoperative neurocognitive disorder. No trial results are reported in this protocol.

Key findings

• The planned trial will randomise 60 patients in a 1:1 ratio to remimazolam or propofol-based total intravenous anaesthesia.
• The primary outcome is the between-group difference in time-weighted average change in regional cerebral oxygen saturation in the prone position versus supine baseline.
• Secondary outcomes include cerebral desaturation events, haemodynamic changes, vasopressor requirements, intraoperative complications and postoperative neurocognitive disorder.

Why it matters

Prone spine surgery may compromise cerebral perfusion, and the abstract identifies particular concern in elderly patients. Comparing these anaesthetic approaches using continuous cerebral oxygenation monitoring may clarify whether their effects differ and provide evidence on related haemodynamic and postoperative outcomes. As this is a protocol, it establishes the question and planned measures rather than evidence of benefit or harm.

What to keep in mind

This is a protocol, so it reports no outcome results. The planned trial is single-centre and includes 60 patients.