Actively Recruiting
Remimazolam vs. Midazolam for Sedation and Cognitive Outcomes in Orthopedic Surgery
Led by Romanian Society for Enteral and Parenteral Nutrition · Updated on 2025-10-01
120
Participants Needed
1
Research Sites
19 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Remimazolam vs. Midazolam for Sedation and Cognitive Outcomes in Orthopedic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Patient refusal to participate
- Mini-Cog score less than 3 (significant cognitive impairment)
- Severe hepatic or renal failure
- Known allergy to benzodiazepines or propofol
- History of benzodiazepine dependence
AI-Screening
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Trial Site Locations
Total: 1 location
1
Clinical Emergency Hospital of Bucharest
Bucharest, Romania
Actively Recruiting
Research Team
A
Ana Maria Dumitriu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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