Trial reportBMC anesthesiology2025
Remimazolam vs. dexmedetomidine for postoperative sedation in oral tumor patients undergoing free flap reconstruction: a randomized controlled pilot trial.
Trial report in BMC anesthesiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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4 authors.
Funding
Abstract
backgroundPatients with oral tumors undergoing free-flap reconstruction require postoperative sedation to improve endotracheal tube tolerance and prevent emergence agitation. While remimazolam offers theoretical hemodynamic advantages over dexmedetomidine, clinical evidence in this context remains limited. This trial compared the efficacy and safety of both agents for sedation after microvascular reconstruction.
methodsIn this randomized, double-blind trial (September 2021-November 2022), 60 patients were enrolled. Upon PACU admission, patients received continuous infusions of remimazolam (0.25 mg·kg⁻¹·h⁻¹) or dexmedetomidine (0.4 µg·kg⁻¹·h⁻¹), titrated to a Ramsay Score of 2-3. The primary outcome was PACU emergence agitation incidence (RASS ≥ + 2). Secondary outcomes included delirium, pain, nausea/vomiting, sleep quality, hospital stay, and complications.
resultsThe final analysis included 57 patients (remimazolam n = 29, dexmedetomidine n = 28) due to consent withdrawal. Emergence agitation incidence was comparable (27.6% vs. 25.0%, p > 0.999; risk difference 2.6% [95% CI: - 21.5-26.7%]). Remimazolam significantly reduced colloid use in PACU (3.4% vs. 32.1%, p = 0.005). No significant differences in secondary outcomes (delirium, pain scores, nausea/vomiting, hospital stay).
conclusionsRemimazolam and dexmedetomidine demonstrated equivalent efficacy in preventing emergence agitation. The significantly reduced colloid requirement with remimazolam suggests enhanced hemodynamic stability, potentially benefiting flap perfusion. Combined with its rapid-offset profile, remimazolam is a viable alternative for postoperative sedation in microvascular reconstruction.
trial registrationChinese Clinical Trial Registry, www.chictr.org.cn , ChiCTR2100048342. Registered on 05/07/2021.
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