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Remimazolam Concentration and Sedation Depth During Lower Extremity Surgery Under Spinal Anesthesia
Sponsor: Seoul National University Hospital
Summary
This study will examine how the amount of remimazolam predicted to reach its site of action relates to the depth of sedation during lower extremity surgery under spinal anesthesia. Remimazolam is a sedative used to help patients relax and feel sleepy during surgery. People may respond differently to the same amount of this medicine, and age may explain some of these differences. Sixty adults will be enrolled at Seoul National University Hospital, with 20 participants in each age group: 19-49 years, 50-69 years, and 70 years or older. All participants will receive remimazolam using the same stepwise dose-adjustment rules. The dose will be adjusted according to repeated assessments of responsiveness. Researchers will record sedation scores, medication delivery, brain-wave signals, vital signs, recovery, and side effects. After surgery, a computer model will estimate the remimazolam concentration at its site of action. These estimates will not be available to the clinical team during surgery. The main goal is to measure how much the concentration associated with the target level of sedation varies between patients. The study will also examine the effect of age and whether early responses can help predict an individual patient's later response.
Official title: Relationship Between Model-Predicted Effect-Site Concentration and Sedation Depth During Titrated Remimazolam Sedation for Lower Extremity Surgery Under Spinal Anesthesia: An Age-Stratified Prospective Study
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-10-30
Completion Date
2027-10
Last Updated
2026-10-13
Healthy Volunteers
No
Interventions
Remimazolam
Remimazolam besylate is prepared at 1 mg/mL. After spinal anesthesia, 2.5 mg is infused intravenously over 1 minute, followed by 0.2 mg/kg/h. MOAA/S is assessed at 1-5 minutes after loading and then every 5 minutes. Increase by 0.05 mg/kg/h for MOAA/S \>3; decrease by 0.05 mg/kg/h for MOAA/S \<=2, maintaining the minimum rate if already at 0.05 mg/kg/h. Permitted range: 0.05-0.8 mg/kg/h. Stop infusion for MOAA/S \<=1 or airway/respiratory impairment; resume at the minimum rate after recovery, with flumazenil if clinically indicated. Stop remimazolam and consider another sedative if MOAA/S remains \>3 at the maximum rate. Stop infusion at the start of muscle-layer closure. Assess MOAA/S every 5 minutes after cessation until MOAA/S 5. Opioids and other sedatives are not coadministered during the study regimen.
Locations (1)
Seoul National University Hospital
Seoul, South Korea