NCT07113483 Remimazolam vs. Midazolam for Sedation and Cognitive Outcomes in Orthopedic Surgery
| NCT ID | NCT07113483 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Romanian Society for Enteral and Parenteral Nutrition |
| Condition | Postoperative Cognitive Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 120 participants in total. It began in 2025-10-01 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Liliana Mirea, Associate Professor, MD
PRINCIPAL INVESTIGATOR
Clinical Emergency Hospital of Bucharest
Frequently Asked Questions
Who can join the NCT07113483 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Postoperative Cognitive Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07113483 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 120 participants.
Is NCT07113483 currently recruiting?
Yes, NCT07113483 is actively recruiting participants. Contact the research team at cotae_ana_maria@yahoo.com for enrollment information.
Where is the NCT07113483 trial being conducted?
This trial is being conducted at Bucharest, Romania.
Who is sponsoring the NCT07113483 clinical trial?
NCT07113483 is sponsored by Romanian Society for Enteral and Parenteral Nutrition. The principal investigator is Liliana Mirea, Associate Professor, MD at Clinical Emergency Hospital of Bucharest. The trial plans to enroll 120 participants.