Remimazolam versus Midazolam for sedation and early thinking recovery in older adults having orthopedic surgery
Official title: Randomized, Double-Blind, 2x2 Factorial Trial of Remimazolam vs. Midazolam on Sedation and Early Cognitive Outcomes in Patients Undergoing Traumatic or Non-Traumatic Orthopedic Surgery With Regional Anesthesia
Run by Romanian Society for Enteral and Parenteral Nutrition · NCT07113483 · Data updated 2026-11-12
This will test whether remimazolam or midazolam gives better sedation and faster early recovery of thinking and memory for people 65 and older undergoing orthopedic surgery with regional anesthesia.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Romanian Society for Enteral and Parenteral Nutrition Academic / other |
| Locations | 1 site (Bucharest) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | January 1, 2026 |
| Study ends | February 15, 2026 |
| Registry record updated | October 1, 2025 |
| Trial ID | NCT07113483 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 65 or older scheduled for traumatic or non-traumatic orthopedic surgery under regional anesthesia with a baseline Mini-Cog score ≥3 and without severe hepatic or renal failure.
✕Probably not a fit
Patients with moderate-to-severe baseline cognitive impairment, severe liver or kidney failure, benzodiazepine allergy or dependence, or those receiving general anesthesia are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized, double-blind, single-center Phase 3 trial comparing remimazolam and midazolam for sedation during orthopedic procedures performed under regional anesthesia in patients aged 65 and older. The design uses a 2x2 factorial randomization creating four arms (remimazolam or midazolam crossed with traumatic vs non‑traumatic cases) with blinding of patients and staff. Investigators will monitor sedation depth, blood pressure, heart rate, adverse events, adjunct propofol use, and early cognitive recovery using standardized assessments (including CAM-ICU) at defined time points after surgery. Safety oversight is provided by a DSMB and the analysis plan includes pre-specified primary and secondary endpoints for cognitive and hemodynamic outcomes.
Why it matters
Potential benefit: If successful, the trial could show that remimazolam provides safer sedation with faster early cognitive recovery and fewer hemodynamic problems in older orthopedic patients.
How similar studies have gone: Previous procedural and anesthetic studies have shown remimazolam produces rapid onset/offset and favorable recovery compared with some sedatives, but head-to-head evidence specifically on early postoperative cognitive outcomes in older orthopedic patients is limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Clinical Emergency Hospital of Bucharest
Bucharest, Romania Recruiting
Study contacts
- Principal investigator: Liliana Mirea, Associate Professor, MD — Clinical Emergency Hospital of Bucharest
- Study coordinator: Ana Maria Dumitriu, MD, PhD
- Email: cotae_ana_maria@yahoo.com
- Phone: +40 721 277 447
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.