Postoperative Cognitive DysfunctionPhase 3REMIND-ORTHONCT07113483
Remimazolam vs. Midazolam for Sedation and Cognitive Outcomes in Orthopedic Surgery
A Phase 3 study testing Midazolam and REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO] in people with Postoperative Cognitive Dysfunction and Orthopedic Procedures, run by Romanian Society for Enteral and Parenteral Nutrition at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Orthopedic Procedures, Postoperative Pain Management
- What is being tested?
- Midazolam and REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteRomania
- Study dates
- 1 Oct 2025to 15 Feb 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site, 1 recruiting
- Recruiting
Clinical Emergency Hospital of Bucharest
Bucharest
Ana Maria Dumitriu, MD, PhD, +40 721 277 447, cotae_ana_maria@yahoo.com
About this study
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
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.
Read more
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.
Read the detailed description
- Background and Rationale
- Importance of effective sedation during orthopedic surgery under regional anesthesia
- Limitations of current sedative agents (Midazolam)
- Potential advantages of Remimazolam (rapid onset/offset, safety profile)
- Gaps in knowledge about cognitive outcomes post-procedure in elderly patients
- Study Objectives
- Primary: Compare Remimazolam vs. Midazolam effects on sedation and early cognitive recovery
- Secondary: Hemodynamics, recovery time, adverse events, patient satisfaction
- Study Design
- Prospective, randomized, double-blind, 2x2 factorial
- Four arms: Remimazolam/traumatic, Remimazolam/non-traumatic, Midazolam/traumatic, Midazolam/non-traumatic
- Single-center study
- Patient Population and Inclusion/Exclusion Criteria
- Age, surgery type, cognitive baseline, health status
- Intervention Details
- Drug dosing protocols
- Use of adjunct propofol
- Blinding and randomization procedures
- Outcome Measures
- Primary and secondary endpoints
- Timing and methods of cognitive assessment (CAM-ICU)
- Hemodynamic monitoring
- Recording adverse events
- Data Collection and Monitoring
- Schedule of assessments
- Safety monitoring by DSMB
- Data confidentiality and storage
- Statistical Analysis Plan
- Sample size rationale
- Statistical methods for primary and secondary outcomes
- Handling of missing data and confounders
- Significance and Impact
- Potential to improve sedation choice in elderly orthopedic patients
- Benefits for patient safety, recovery quality, and healthcare resources
Sample Detailed Description Text (expand with specifics and references):
Background and Rationale
Orthopedic surgeries in elderly patients often require sedation alongside regional anesthesia to ensure patient comfort and procedural success. Midazolam, a commonly used benzodiazepine, has a well-known sedative profile but is associated with prolonged sedation and cognitive impairment postoperatively in some cases. Remimazolam is a newer ultra-short-acting benzodiazepine with rapid onset and offset, potentially offering better control over sedation depth and faster cognitive recovery.
Currently, limited data exist comparing these agents in the context of orthopedic surgery, especially among older adults who are at higher risk for postoperative cognitive dysfunction. This study aims to fill this gap by rigorously comparing remimazolam and midazolam in a controlled clinical trial setting.
Objectives
The primary objective is to evaluate the impact of remimazolam versus midazolam on periprocedural sedation quality and early postoperative cognitive function, measured by the Confusion Assessment Method (CAM) within 72 hours after surgery.
Secondary objectives include assessment of hemodynamic stability, recovery profiles, incidence of adverse events, difficulty in spinal puncture, and patient satisfaction.
Study Design
This is a prospective, randomized, double-blind, 2x2 factorial trial conducted at the Clinical Emergency Hospital of Bucharest. Patients aged 65 and older undergoing traumatic or non-traumatic orthopedic surgery under regional anesthesia will be randomized into one of four groups.
Interventions
Patients will receive either remimazolam or midazolam following standardized dosing protocols. Propofol will be administered as an adjunct for maintenance sedation, with doses recorded and analyzed.
Outcome Measures
Primary outcomes include CAM scores assessed at multiple postoperative time points. Secondary outcomes include detailed monitoring of blood pressure, heart rate, time to full orientation, PACU stay length, adverse event rates, and subjective patient satisfaction via Likert scales.
Data Collection and Monitoring
Safety and efficacy data will be collected by blinded assessors. An independent Data and Safety Monitoring Board will oversee study progress and patient safety.
Statistical Analysis
Sample size calculations anticipate enrolling 120 participants, ensuring adequate power to detect clinically relevant differences in cognitive outcomes. Data will be analyzed using ANOVA, Kaplan-Meier, and regression models as appropriate.
Significance
This trial aims to provide evidence to guide sedative choice in elderly orthopedic patients, balancing effective sedation with cognitive safety, potentially improving patient outcomes and healthcare delivery.
- Conditions
- Postoperative Cognitive Dysfunction, Orthopedic Procedures, Postoperative Pain Management, Hip Fracture
- Being tested
- Midazolam, REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]
- Keywords
- Remimazolam, Midazolam, Regional Anesthesia, Sedation, Cognitive dysfunction, Elderly patients, Trauma
- Medical subject headings
- Postoperative Cognitive Complications, Hip Fractures, Cognitive Dysfunction, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Also called Dormicum, Versed, Midazolam Hydrochloride
Midazolam:
A commonly used benzodiazepine for sedation, administered intravenously at 0.025-0.05 mg/kg with supplemental doses as required. Known for effective anxiolysis and sedation but with a longer recovery profile compared to remimazolam.
REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]Drug
Also called ByfaByfavo, Remimazolam Besylate, Remimazolam
Remimazolam:
A novel, ultra-short-acting benzodiazepine used for procedural sedation. Administered intravenously at 5 mg over 1 minute with supplemental dosing as needed. Characterized by rapid onset and quick recovery, with minimal residual sedation.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam with Traumatic Orthopedic Surgery | Active comparator | 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. Receives: Drug: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO] |
| Remimazolam with Non-Traumatic Orthopedic Surgery | Active comparator | 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. Receives: Drug: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO] |
| Midazolam with Traumatic Orthopedic Surgery | Active comparator | 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. Receives: Drug: Midazolam |
| Midazolam with Non-Traumatic Orthopedic Surgery | Active comparator | Participants receive intravenous Midazolam sedation during regional anesthesia for elective (non-traumatic) orthopedic surgery. Sedation dosing and propofol adjunct use follow the study protocol. Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early postoperative cognitive function assessed by the Confusion Assessment Method (CAM) score
Cognitive function will be evaluated using the Confusion Assessment Method (CAM) to detect delirium and acute cognitive changes between 24 and 72 hours postoperatively. This tool assesses acute confusion and cognitive impairment to determine the impact of remimazolam vs. midazolam sedation on early postoperative cognition.
Unit of Measure: CAM score (binary outcome: presence or absence of delirium) Scale Information: CAM is a diagnostic algorithm (Yes/No criteria). A positive CAM indicates the presence of delirium.
Measured: 24 to 72 hours after surgery
Secondary outcomes (8)
Intraoperative blood pressure
Systolic and diastolic blood pressure will be monitored intraoperatively to assess hemodynamic stability during sedation.
Unit of Measure: mmHg
Measured: Intraoperative period up to 72 hours post-surgery
Intraoperative heart rate
Heart rate will be monitored to assess the effect of sedation on cardiovascular parameters.
Unit of measure: Beats per minute (bpm)
Measured: Intraoperative period and up to 72 h postoperative
Vasopressor requirement
Dose and duration of vasopressors used during surgery will be recorded. Unit of Measure: μg/kg/min
Measured: Intraoperative period and up to 72h postoperative
Time to full orientation after surgery
Time taken for the patient to become fully oriented postoperatively will be measured. Unit of Measure: Minutes
Measured: Post-anesthesia care unit (PACU) period
Length of stay in PACU
Total duration of PACU stay postoperatively will be recorded. Unit of Measure: Minutes
Measured: Post-anesthesia care unit (PACU) period
Spinal Puncture Difficulty Score
Degree of difficulty encountered during spinal anesthesia, based on a 0-5 scale. Unit of Measure: Score (0-5; higher = more difficult)
Measured: During spinal puncture
Postoperative pain (VAS score)
Pain will be measured using the Visual Analog Scale at multiple time points up to 72 hours. VAS score (0-10; higher = worse pain)
Measured: 0-72 hours postoperatively
Patient satisfaction
Patient satisfaction with anesthesia and perioperative care will be rated using a 5-point Likert scale. Unit of Measure: Likert score (1-5)
Measured: Up to 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Study medications (Remimazolam and Midazolam) will be prepared in identical syringes by a pharmacist not involved in patient care or outcome assessment. Both participants and clinical staff (anesthesiologists, nurses, outcome assessors) will be blinded to treatment allocation. Emergency unblinding is allowed only in the event of severe adverse events.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Romanian Society for Enteral and Parenteral Nutrition
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liliana Mirea, Associate Professor, MD, Principal investigator, Clinical Emergency Hospital of BucharestAna Maria Dumitriu, MD, PhD, Study director, Clinical Emergency Hospital of Bucharest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113483
- Sponsor's protocol ID
- 35782025
- Acronym
- REMIND-ORTHO
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, individual participant data (IPD) will not be shared due to concerns about patient privacy, data confidentiality, and institutional policies. Data sharing may be reconsidered in the future based on study results and evolving regulations.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07113483
- Acronym / sponsor ID
- REMIND-ORTHO / 35782025
- Conditions
- Postoperative Cognitive Dysfunction, Orthopedic Procedures, Postoperative Pain Management, Hip Fracture
- Keywords
- Remimazolam, Midazolam, Regional Anesthesia, Sedation, Cognitive dysfunction, Elderly patients, Trauma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Romanian Society for Enteral and Parenteral NutritionUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Background and Rationale
- Importance of effective sedation during orthopedic surgery under regional anesthesia
- Limitations of current sedative agents (Midazolam)
- Potential advantages of Remimazolam (rapid onset/offset, safety profile)
- Gaps in knowledge about cognitive outcomes post-procedure in elderly patients
- Study Objectives
- Primary: Compare Remimazolam vs. Midazolam effects on sedation and early cognitive recovery
- Secondary: Hemodynamics, recovery time, adverse events, patient satisfaction
- Study Design
- Prospective, randomized, double-blind, 2x2 factorial
- Four arms: Remimazolam/traumatic, Remimazolam/non-traumatic, Midazolam/traumatic, Midazolam/non-traumatic
- Single-center study
- Patient Population and Inclusion/Exclusion Criteria
- Age, surgery type, cognitive baseline, health status
- Intervention Details
- Drug dosing protocols
- Use of adjunct propofol
- Blinding and randomization procedures
- Outcome Measures
- Primary and secondary endpoints
- Timing and methods of cognitive assessment (CAM-ICU)
- Hemodynamic monitoring
- Recording adverse events
- Data Collection and Monitoring
- Schedule of assessments
- Safety monitoring by DSMB
- Data confidentiality and storage
- Statistical Analysis Plan
- Sample size rationale
- Statistical methods for primary and secondary outcomes
- Handling of missing data and confounders
- Significance and Impact
- Potential to improve sedation choice in elderly orthopedic patients
- Benefits for patient safety, recovery quality, and healthcare resources
Sample Detailed Description Text (expand with specifics and references):
Background and Rationale
Orthopedic surgeries in elderly patients often require sedation alongside regional anesthesia to ensure patient comfort and procedural success. Midazolam, a commonly used benzodiazepine, has a well-known sedative profile but is associated with prolonged sedation and cognitive impairment postoperatively in some cases. Remimazolam is a newer ultra-short-acting benzodiazepine with rapid onset and offset, potentially offering better control over sedation depth and faster cognitive recovery.
Currently, limited data exist comparing these agents in the context of orthopedic surgery, especially among older adults who are at higher risk for postoperative cognitive dysfunction. This study aims to fill this gap by rigorously comparing remimazolam and midazolam in a controlled clinical trial setting.
Objectives
The primary objective is to evaluate the impact of remimazolam versus midazolam on periprocedural sedation quality and early postoperative cognitive function, measured by the Confusion Assessment Method (CAM) within 72 hours after surgery.
Secondary objectives include assessment of hemodynamic stability, recovery profiles, incidence of adverse events, difficulty in spinal puncture, and patient satisfaction.
Study Design
This is a prospective, randomized, double-blind, 2x2 factorial trial conducted at the Clinical Emergency Hospital of Bucharest. Patients aged 65 and older undergoing traumatic or non-traumatic orthopedic surgery under regional anesthesia will be randomized into one of four groups.
Interventions
Patients will receive either remimazolam or midazolam following standardized dosing protocols. Propofol will be administered as an adjunct for maintenance sedation, with doses recorded and analyzed.
Outcome Measures
Primary outcomes include CAM scores assessed at multiple postoperative time points. Secondary outcomes include detailed monitoring of blood pressure, heart rate, time to full orientation, PACU stay length, adverse event rates, and subjective patient satisfaction via Likert scales.
Data Collection and Monitoring
Safety and efficacy data will be collected by blinded assessors. An independent Data and Safety Monitoring Board will oversee study progress and patient safety.
Statistical Analysis
Sample size calculations anticipate enrolling 120 participants, ensuring adequate power to detect clinically relevant differences in cognitive outcomes. Data will be analyzed using ANOVA, Kaplan-Meier, and regression models as appropriate.
Significance
This trial aims to provide evidence to guide sedative choice in elderly orthopedic patients, balancing effective sedation with cognitive safety, potentially improving patient outcomes and healthcare delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Study medications (Remimazolam and Midazolam) will be prepared in identical syringes by a pharmacist not involved in patient care or outcome assessment. Both participants and clinical staff (anesthesiologists, nurses, outcome assessors) will be blinded to treatment allocation. Emergency unblinding is allowed only in the event of severe adverse events.
| Arm | Type | Receives |
|---|---|---|
| Remimazolam with Traumatic Orthopedic Surgery | Active comparator | Drug: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]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. |
| Remimazolam with Non-Traumatic Orthopedic Surgery | Active comparator | Drug: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]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. |
| Midazolam with Traumatic Orthopedic Surgery | Active comparator | Drug: MidazolamParticipants 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. |
| Midazolam with Non-Traumatic Orthopedic Surgery | Active comparator | Drug: MidazolamParticipants receive intravenous Midazolam sedation during regional anesthesia for elective (non-traumatic) orthopedic surgery. Sedation dosing and propofol adjunct use follow the study protocol. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidazolamAlso: Dormicum, Versed, Midazolam HydrochlorideMidazolam: A commonly used benzodiazepine for sedation, administered intravenously at 0.025-0.05 mg/kg with supplemental doses as required. Known for effective anxiolysis and sedation but with a longer recovery profile compared to remimazolam. | Drug | Midazolam with Non-Traumatic Orthopedic Surgery, Midazolam with Traumatic Orthopedic Surgery |
| REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]Also: ByfaByfavo, Remimazolam Besylate, RemimazolamRemimazolam: A novel, ultra-short-acting benzodiazepine used for procedural sedation. Administered intravenously at 5 mg over 1 minute with supplemental dosing as needed. Characterized by rapid onset and quick recovery, with minimal residual sedation. | Drug | Remimazolam with Non-Traumatic Orthopedic Surgery, Remimazolam with Traumatic Orthopedic Surgery |
Primary outcome
Early postoperative cognitive function assessed by the Confusion Assessment Method (CAM) score
Time frame: 24 to 72 hours after surgery
Cognitive function will be evaluated using the Confusion Assessment Method (CAM) to detect delirium and acute cognitive changes between 24 and 72 hours postoperatively. This tool assesses acute confusion and cognitive impairment to determine the impact of remimazolam vs. midazolam sedation on early postoperative cognition. Unit of Measure: CAM score (binary outcome: presence or absence of delirium) Scale Information: CAM is a diagnostic algorithm (Yes/No criteria). A positive CAM indicates the presence of delirium.
8 secondary outcomes
Intraoperative blood pressure
Time frame: Intraoperative period up to 72 hours post-surgery
Intraoperative heart rate
Time frame: Intraoperative period and up to 72 h postoperative
Vasopressor requirement
Time frame: Intraoperative period and up to 72h postoperative
Time to full orientation after surgery
Time frame: Post-anesthesia care unit (PACU) period
Length of stay in PACU
Time frame: Post-anesthesia care unit (PACU) period
Spinal Puncture Difficulty Score
Time frame: During spinal puncture
Postoperative pain (VAS score)
Time frame: 0-72 hours postoperatively
Patient satisfaction
Time frame: Up to 72 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No. At this time, individual participant data (IPD) will not be shared due to concerns about patient privacy, data confidentiality, and institutional policies. Data sharing may be reconsidered in the future based on study results and evolving regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liliana Mirea, Associate Professor, MD principal investigator
Clinical Emergency Hospital of Bucharest
Ana Maria Dumitriu, MD, PhD study director
Clinical Emergency Hospital of Bucharest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Midazolam and REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO] in people with Postoperative Cognitive Dysfunction and Orthopedic Procedures, run by Romanian Society for Enteral and Parenteral Nutrition at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Maria Dumitriu, MD, PhD (+40 721 277 447, cotae_ana_maria@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early postoperative cognitive function assessed by the Confusion Assessment Method (CAM) score (time frame: 24 to 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.