30
Participants
Start Date
July 1, 2025
Primary Completion Date
July 1, 2026
Study Completion Date
June 1, 2027
Remimazolam Besylate
"This is the first clinical trial evaluating Remimazolam's pharmacokinetics (PK), pharmacodynamics (PD), and safety in renal transplant recipients-a population with unique physiological alterations due to end-stage renal disease and graft reperfusion. Key differentiators include:~Population-Specific Dosing Protocol:~Induction: 6 mg/kg/h until MOAA/S ≤1 (vs. 5-12 mg/kg/h in general surgery).~Maintenance: Titrated (0.5-2 mg/kg/h) to Narcotrend Index 27-60 (lower than typical BIS 40-60 targets), accounting for altered drug metabolism post-transplant.~Transplant-Specific Context:~Administered alongside standard immunosuppressants (methylprednisolone 750 mg + furosemide 60 mg at reperfusion) but prohibits common sedatives (midazolam/propofol) to isolate Remimazolam's effects.~PK/PD sampling accounts for graft function dynamics (e.g., blood draws during reperfusion and post-op days 1-6).~Exploratory Genetic Analysis:~First study linking VDR/"
RECRUITING
Shandong First Medical University Hospital, Jinan
Qianfoshan Hospital
OTHER