Remimazolam vs. Midazolam for Sedation and Cognitive Outcomes in Orthopedic Surgery
Randomized, Double-Blind, 2x2 Factorial Trial of Remimazolam vs. Midazolam on Sedation and Early Cognitive Outcomes in Patients Undergoing Traumatic or Non-Traumatic Orthopedic Surgery With Regional Anesthesia
Romanian Society for Enteral and Parenteral Nutrition
120 participants
Oct 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria5
- 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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Interventions
Midazolam: A commonly used benzodiazepine for sedation, administered intravenously at 0.025-0.05 mg/kg with supplemental doses as required. Known for effective anxiolysis and sedation but with a longer recovery profile compared to remimazolam.
Remimazolam: A novel, ultra-short-acting benzodiazepine used for procedural sedation. Administered intravenously at 5 mg over 1 minute with supplemental dosing as needed. Characterized by rapid onset and quick recovery, with minimal residual sedation.
Locations(1)
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NCT07113483