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

RecruitingPhase 3Ages 65 Years - anyAllRomanian Society for Enteral and Parenteral Nutri…
NCT07113483 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults aged 65 years or older. * Scheduled for traumatic or non-traumatic orthopedic surgery under regional anesthesia. * Able to provide informed consent or have a legally authorized representative provide consent. Exclusion Criteria: * Patient refusal to participate. * Mini-Cog score less than 3 (indicative of significant cognitive impairment). * Severe hepatic or renal failure. * Known allergy to benzodiazepines or propofol. * History of benzodiazepine dependence.
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What it tests

  • Midazolam
  • REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]
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Where

1 site
Clinical Emergency Hospital of Bucharest
Bucharest, Romania
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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