Remimazolam vs. Midazolam for Sedation and Cognitive Outcomes in Orthopedic Surgery
Recruiting
Phase 3
Interventional Study
Postoperative Cognitive Dysfunction
Orthopedic Procedures
Postoperative Pain Management
Hip Fracture
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 65 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 120 (estimated)
- Sponsor
- Romanian Society for Enteral and Parenteral Nutrition · Other
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About This Trial
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 pa…
Trial Locations
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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.
* Min…
Contacts