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Search / Trial NCT07113483

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

Launched by ROMANIAN SOCIETY FOR ENTERAL AND PARENTERAL NUTRITION · Aug 7, 2025

Trial Information

Current as of August 24, 2025

Not yet recruiting

Keywords

Remimazolam Midazolam Regional Anesthesia Sedation Cognitive Dysfunction Elderly Patients Trauma

ClinConnect Summary

This clinical trial is comparing two medicines, Remimazolam and Midazolam, which are used to help patients relax or sleep (sedation) during orthopedic surgeries, like those for broken bones or hip problems. The study focuses on older adults, aged 65 and up, having surgery with regional anesthesia—where only part of the body is numbed. Researchers want to find out which medicine works better for keeping patients calm during surgery and which one helps the brain recover more quickly after the procedure, especially in terms of thinking and memory.

If you are 65 or older and scheduled for orthopedic surgery, you might be eligible to join, as long as you don’t have serious liver or kidney problems, aren’t allergic to these medicines, and don’t have significant memory or thinking difficulties. During the study, neither you nor the medical team will know which medicine you receive, to keep the results fair. Doctors will watch your sedation levels, vital signs like blood pressure and heart rate, any side effects, and how well your brain functions after surgery. The goal is to find the safest and most comfortable sedation option to help older patients recover better after their surgeries.

Gender

ALL

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.

About Romanian Society For Enteral And Parenteral Nutrition

The Romanian Society for Enteral and Parenteral Nutrition (SREN) is a leading professional organization dedicated to advancing the field of clinical nutrition in Romania. Committed to promoting high standards of care, SREN facilitates research, education, and collaboration among healthcare professionals involved in enteral and parenteral nutrition. Through its initiatives, the society aims to enhance patient outcomes by supporting evidence-based practices and fostering innovation in nutritional therapies. SREN plays a pivotal role in shaping clinical guidelines and advocating for the importance of nutritional support in various medical settings.

Locations

Patients applied

0 patients applied

Trial Officials

Liliana Mirea, Associate Professor, MD

Principal Investigator

Clinical Emergency Hospital of Bucharest

Ana Maria Dumitriu, MD, PhD

Study Director

Clinical Emergency Hospital of Bucharest

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported