drugset / Trial / NCT07113483

Remimazolam vs. Midazolam for Sedation and Cognitive Outcomes in Orthopedic Surgery

NCT07113483

RandomizedFactorialQuadruple-blindTreatment

Summary

This study aims to compare two medications, Remimazolam and Midazolam, used for sedation during orthopedic surgeries performed under regional anesthesia. We want to find out which medication provides better sedation during the procedure and which one affects early recovery of brain function after surgery. Older adults (65 years and above) undergoing surgery for bone injuries or conditions will participate. We will monitor their sedation levels, blood pressure, heart rate, side effects, and how quickly they recover after surgery. We also want to see if either medication causes fewer problems with thinking and memory shortly after surgery. The study is designed so neither the patients nor the medical staff know which medication is being given, to ensure unbiased results. Participants will be randomly assigned to receive either Remimazolam or Midazolam. The information gathered will help doctors choose the safest and most effective sedative for older patients undergoing orthopedic surgeries, potentially improving patient comfort and recovery.

Timeline

Start
2025-10-01
Primary completion
2026-01-01
Completion
2026-02-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Midazolam Small molecule 0.025 mg/kg Intravenous
Comparator Midazolam Small molecule 0.05 mg/kg Intravenous
Comparator Remimazolam Small molecule 5 mg Intravenous

Indications

No indication recorded.