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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Romania
Clinical Emergency Hospital of Bucharest
RECRUITING
Bucharest
Contact Information
Primary
Ana Maria Dumitriu, MD, PhD
cotae_ana_maria@yahoo.com
+40 721 277 447
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2026-02-15
Participants
Target number of participants: 120
Treatments
Active_comparator: Remimazolam with Traumatic Orthopedic Surgery
Participants in this arm receive intravenous Remimazolam sedation during regional anesthesia for traumatic orthopedic surgery. Sedation dosing follows the protocol of 5 mg IV over 1 minute with supplemental doses as needed. Propofol infusion may be used as an adjunct.
Active_comparator: Remimazolam with Non-Traumatic Orthopedic Surgery
Participants receive intravenous Remimazolam sedation during regional anesthesia for elective (non-traumatic) orthopedic surgery. Sedation dosing and adjunct propofol use are consistent with the protocol.
Active_comparator: Midazolam with Traumatic Orthopedic Surgery
Participants receive intravenous Midazolam sedation during regional anesthesia for traumatic orthopedic surgery. Dosing is 0.025-0.05 mg/kg IV with supplemental doses if needed. Propofol may be used as adjunct sedation.
Active_comparator: Midazolam with Non-Traumatic Orthopedic Surgery
Participants receive intravenous Midazolam sedation during regional anesthesia for elective (non-traumatic) orthopedic surgery. Sedation dosing and propofol adjunct use follow the study protocol.
Related Therapeutic Areas
Sponsors
Leads: Romanian Society for Enteral and Parenteral Nutrition

This content was sourced from clinicaltrials.gov