Effects of remimazolam versus propofol on cerebral oxygenation in elderly patients undergoing prone spine surgery: study protocol for a randomised controlled trial
5 affiliations
- 1Department of Anesthesiology, Kameda Medical Center, Kamogawa, Chiba, Japan
- 2Department of Anesthesiology and Perioperative Medicine, Oregon Health & Science University, Portland, Oregon, USA
- 3Department of Anesthesiology and Resuscitology, Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences, Okayama, Okayama, Japan
- 4Advanced Clinical Specialist Center, Kameda Medical Center, Kamogawa, Chiba, Japan
- 5Department of Anesthesiology, University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA
Abstract
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 (rScO ₂ ) will be continuously monitored using near-infrared spectroscopy. The primary outcome is the between-group difference in time-weighted average change in rScO ₂ (ΔrScO ₂ ) 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.
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BibTeX
@article{lazaro2026effects,
title = {{Effects of remimazolam versus propofol on cerebral oxygenation in elderly patients undergoing prone spine surgery: study protocol for a randomised controlled trial}},
author = {Betina Lazaro and Zhuan Jin and Yurie Sugaya and Kenichi Ueda},
journal = {BMJ Open},
year = {2026},
month = oct,
doi = {10.1136/bmjopen-2026-123988},
url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-123988},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Effects of remimazolam versus propofol on cerebral oxygenation in elderly patients undergoing prone spine surgery: study protocol for a randomised controlled trial
AU - Betina Lazaro
AU - Zhuan Jin
AU - Yurie Sugaya
AU - Kenichi Ueda
PY - 2026
DA - 2026/10/07
JO - BMJ Open
DO - 10.1136/bmjopen-2026-123988
UR - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-123988
AB - 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 (rScO ₂ ) will be continuously monitored using near-infrared spectroscopy. The primary outcome is the between-group difference in time-weighted average change in rScO ₂ (ΔrScO ₂ ) 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.
SN - 2044-6055
SN - 2044-6055
ER -