RM-LT Trial Study Design: A Controlled Trial Exploring Remimazolam Besylate–Based Anesthesia in Enhanced Recovery After Liver Transplantation
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Background
Liver transplantation is a complex surgical procedure featuring prolonged operative time and extensive surgical trauma, which results in a high anesthetic risk. Especially during anesthesia induction and the anhepatic-to-reperfusion phases, where marked hemodynamic fluctuations may readily lead to malignant cardiovascular events.
Liver transplantation is associated with numerous postoperative complications, including pulmonary complications, postoperative delirium, acute kidney injury, and delayed emergence, all of which may adversely affect patient prognosis.
Studies on remimazolam besylate (hereafter referred to as remimazolam) have suggested that it has minimal impact on patient hemodynamics. In theory, this renders remimazolam an ideal sedative agent for liver transplantation.
This study aims to verify the hypothesis that the use of remimazolam during liver transplantation can reduce the incidence of postreperfusion syndrome (PRS). In addition, we further explored the effects of remimazolam on postoperative complications in liver transplant recipients, particularly focusing on perioperative liver and kidney function, pulmonary complications, and postoperative delirium.
Methods
This study is a prospective randomized controlled trial. 120 participants aged 18–60 years who are scheduled to undergo liver transplantation under general anesthesia will be enrolled. In the intervention group, remimazolam besylate will be used for anesthesia induction and maintenance at doses of 0.2–0.4 mg/kg and 1–3 mg/kg/h until the end of surgery. In the control group, propofol will be used for anesthesia induction and maintenance at doses of 1–2 mg/kg and 4–12 mg/kg/h until the end of surgery.
In both groups, anesthetic drug doses or sevoflurane administration for intravenous–inhalational combined anesthesia will be adjusted based on vital signs and BIS values. All other anesthetic medications will be conducted according to the anesthetist’s preference and remain consistent.
Discussion
This trial will investigate whether remimazolam besylate can be used during liver transplantation to reduce the incidence of postreperfusion syndrome. It will also examine whether the drug provides potential benefits regarding perioperative complications such as postoperative delirium and acute kidney injury.
Trial Registration
Chinese Clinical Trial Registry,ChiCTR2500095774, registered on January 13, 2025
Strengths and limitations of this study
Strengths
This study is the first clinical research on the application of this drug in liver transplantation surgeries, and it is of a prospective nature.
The expected results of this study can provide a safer and more advanced drug selection model for liver transplantation surgeries.
limitations
Due to the urgency of liver transplantation surgeries, we cannot guarantee that the donor conditions are relatively consistent.
The general conditions of patients undergoing liver transplantation are complex and inconsistent, and we cannot predict in advance whether the baseline data of the two groups are consistent.
