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Recruiting Phase 3 NCT07113483

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

Trial Parameters

Condition Postoperative Cognitive Dysfunction
Sponsor Romanian Society for Enteral and Parenteral Nutrition
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 120
Sex ALL
Min Age 65 Years
Max Age N/A
Start Date 2025-10-01
Completion 2026-01-01
Interventions
MidazolamREMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]

Brief 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.

Eligibility Criteria

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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