ArticleBMJ open2025
Comparison of remimazolam-flumazenil versus propofol on delayed emergence from anaesthesia in major spine surgery: protocol for a multicentre, single-blinded, randomised controlled trial.
Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionProlonged infusion of anaesthetics is associated with delayed emergence (DE) from general anaesthesia due to residual drug effects. Remimazolam besylate, a novel ultrashort-acting benzodiazepine, exhibits minimal accumulation, and its sedative effects can be reversed with flumazenil. This study aimed to evaluate the incidence of DE from anaesthesia using remimazolam-flumazenil or propofol in patients undergoing major spine surgery. METHODS AND ANALYSIS: This multicentre, randomised controlled trial will be conducted in five hospitals in Hunan Province, China. Approximately 164 patients undergoing major spine surgery lasting >3 hours will be randomly assigned to two groups in a 1:1 ratio. In the remimazolam-flumazenil group, remimazolam will be administered for anaesthesia induction and maintenance, followed by flumazenil for reversal after surgery, whereas propofol will be administered in the propofol group. The primary outcome is the incidence of DE from anaesthesia. The secondary outcomes include the time to obey verbal command, time to bispectral index over 80, time to extubation, length of stay in the post-anaesthesia care unit (PACU), Richmond Agitation-Sedation Scale scores and Modified Aldrete scores on arrival at PACU, at 30 and 60 min, as well as adverse events throughout recovery. All statistical tests will be conducted using SPSS version 27.0 (IBM Corp., Armonk, NY, USA). A ETHICS AND DISSEMINATION: This randomised controlled trial protocol has received ethical approval from the Second Xiangya Hospital, Central South University (Approval number: LYEC2024-0357). All participants will be required to provide written informed consent before study enrolment. The findings will be disseminated at academic conferences and published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ChiCTR2400092451.
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