BMJ open · 2026
Effects of remimazolam versus propofol on cerebral oxygenation in elderly patients undergoing prone spine surgery: study protocol for a randomised controlled trial.
Протокол клинического исследованияСравнительное исследованиеСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Lazaro Betina, Jin Zhuan, Sugaya Yurie, Ueda Kenichi
Аннотация
INTRODUCTION: Prone spine surgery may increase the risk of cerebral hypoperfusion and postoperative neurological adverse events, particularly in elderly patients. Remimazolam is a novel ultra-short-acting benzodiazepine anaesthetic that may provide greater haemodynamic stability than propofol. However, its effects on cerebral oxygenation during prone spine surgery remain unclear, indicating clinical equipoise between remimazolam and propofol. This study compares the effects of remimazolam and propofol on cerebral oxygenation in elderly patients undergoing thoracic or lumbar spine surgery in the prone position under general anaesthesia.
METHODS AND ANALYSIS: This prospective randomised controlled trial will be conducted at a single tertiary medical centre. Sixty patients scheduled for elective lumbar or thoracic spine surgery in prone position will be randomly assigned in a 1:1 ratio to receive either remimazolam or propofol-based total intravenous anaesthesia. Regional cerebral oxygen saturation (rScO2) will be continuously monitored using near-infrared spectroscopy. The primary outcome is the between-group difference in time-weighted average change in rScO2 (ΔrScO2) in the prone position relative to baseline values in the supine position prior to the induction of anaesthesia. Secondary outcomes include cerebral desaturation events, intraoperative haemodynamic changes, vasopressor requirements, intraoperative complications and postoperative neurocognitive disorder assessed using Mini-Cog and Ultra-Brief Confusion Assessment Method.
ETHICS AND DISSEMINATION: The study was approved by the Clinical Research Review Board of Kameda Medical Center (approval number 25-130; approval date: 5 February 2026). Written informed consent will be obtained from all participants before enrolment. The findings will be disseminated through publication in peer-reviewed journals and presentation at academic conferences.
TRIAL REGISTRATION NUMBER: Japan Registry of Clinical Trials, jRCT1031250782, first registered on 6 March 2026.
METHODS AND ANALYSIS: This prospective randomised controlled trial will be conducted at a single tertiary medical centre. Sixty patients scheduled for elective lumbar or thoracic spine surgery in prone position will be randomly assigned in a 1:1 ratio to receive either remimazolam or propofol-based total intravenous anaesthesia. Regional cerebral oxygen saturation (rScO2) will be continuously monitored using near-infrared spectroscopy. The primary outcome is the between-group difference in time-weighted average change in rScO2 (ΔrScO2) in the prone position relative to baseline values in the supine position prior to the induction of anaesthesia. Secondary outcomes include cerebral desaturation events, intraoperative haemodynamic changes, vasopressor requirements, intraoperative complications and postoperative neurocognitive disorder assessed using Mini-Cog and Ultra-Brief Confusion Assessment Method.
ETHICS AND DISSEMINATION: The study was approved by the Clinical Research Review Board of Kameda Medical Center (approval number 25-130; approval date: 5 February 2026). Written informed consent will be obtained from all participants before enrolment. The findings will be disseminated through publication in peer-reviewed journals and presentation at academic conferences.
TRIAL REGISTRATION NUMBER: Japan Registry of Clinical Trials, jRCT1031250782, first registered on 6 March 2026.