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.
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.
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.
Factorial
Midazolam
DrugMidazolam: 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 BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]
DrugRemimazolam: 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.
Early postoperative cognitive function assessed by the Confusion Assessment Method (CAM) score
Cognitive function will be evaluated using the Confusion Assessment Method (CAM) to detect delirium and acute cognitive changes between 24 and 72 hours postoperatively. This tool assesses acute confusion and cognitive impairment to determine the impact of remimazolam vs. midazolam sedation on early postoperative cognition. Unit of Measure: CAM score (binary outcome: presence or absence of delirium) Scale Information: CAM is a diagnostic algorithm (Yes/No criteria). A positive CAM indicates the presence of delirium.
Intraoperative blood pressure
Systolic and diastolic blood pressure will be monitored intraoperatively to assess hemodynamic stability during sedation. Unit of Measure: mmHg
Intraoperative heart rate
Heart rate will be monitored to assess the effect of sedation on cardiovascular parameters. Unit of measure: Beats per minute (bpm)
Vasopressor requirement
Dose and duration of vasopressors used during surgery will be recorded. Unit of Measure: μg/kg/min
Time to full orientation after surgery
Time taken for the patient to become fully oriented postoperatively will be measured. Unit of Measure: Minutes
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