RemimazolamPhase 2NCT06398275
Remimazolam for Emergence Delirium Prevention in Patients Undergoing Rhinoseptoplasty, FESS or Septoplasty
A Phase 2 study testing Remimazolam 20 MG Injection [Byfavo] and NaCl 0.9% in people with Remimazolam and Emergence Delirium, run by University Hospital of Split at 1 site in Croatia.
Trial summary
The aim of this research is to confirm the effectiveness of remimazolam in preventing delirium during recovery from anesthesia in adult patients who have undergone one of the rhinological surgeries (septoplasty, rhinoseptoplasty or functional endoscopic sinus surgery). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Remimazolam, Emergence Delirium, Rhinoplasty
- What is being tested?
- Remimazolam 20 MG Injection [Byfavo] and NaCl 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCroatia
- Study dates
- 6 Mar 2024to Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for rhinoplasty, rhinoseptoplasty or FESS
- ASA I or II
Who cannot join
- pregnancy
- patients treated with psychiatric medication (in the time of operation or 6 months prior to operation)
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
UH Split
Split
Grgur Prižmić, +385994213808, gregorio.prizmic@gmail.com
About this study
The aim of this research is to confirm the effectiveness of remimazolam in preventing delirium during recovery from anesthesia in adult patients who have undergone one of the rhinological surgeries (septoplasty, rhinoseptoplasty or functional endoscopic sinus surgery).
Patients aged 18-65, ASA classification I-II will be anesthetized with balanced anesthesia maintained with sevoflurane and will be randomized into two groups. The first group will receive remimazolam before anesthesia, while the second will receive normal saline solution.
The main outcome of the study will be the presence/absence of delirium during anesthesia recovery, while the secondary outcome will be the postoperative pain level, the length of stay in the recovery room, the presence of unwanted events in the recovery room, and the presence of postoperative mood changes.
- Conditions
- Remimazolam, Emergence Delirium, Rhinoplasty
- Being tested
- Remimazolam 20 MG Injection [Byfavo], NaCl 0.9%
- Keywords
- Remimazolam
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam 20 MG Injection [Byfavo]Drug
Remimazolam 0.1 mg/kg intravenous injection
NaCl 0.9%Drug
NaCl 0.9% 0.04 mL/kg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Remimazolam 20 MG Injection [Byfavo] |
| 2 | Placebo comparator | Not described Receives: Drug: NaCl 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Richmond agitation sedation scale
Measured: Immediately after extubation and every five minutes after that for half hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start6 Mar 2024
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RemimazolamStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Split
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grgur Prižmić, University Hospital of Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398275
- Sponsor's protocol ID
- 520-03/24-01/14
- Status last verified
- Jan 2024
- First submitted
- 29 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Prizmic G, Peris F, Jozeljic Pesic M, Mitar AM, Bego A, Perkovic SP, Stojanovic Stipic S. Remimazolam Bolus Prevents Emergence Agitation After Rhinologic Surgery: A Randomized, Triple-Blind, Controlled Trial. Med Sci (Basel). 2026 Mar 10;14(1):129. doi: 10.3390/medsci14010129.
PubMed 41892844
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remimazolam for Emergence Delirium Prevention in Patients Undergoing Rhinoseptoplasty, FESS or Septoplasty
- ClinicalTrials.gov ID
- NCT06398275
- Acronym / sponsor ID
- 520-03/24-01/14
- Conditions
- Remimazolam, Emergence Delirium, Rhinoplasty
- Keywords
- Remimazolam
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital of SplitUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 3 May 2024 (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.
The aim of this research is to confirm the effectiveness of remimazolam in preventing delirium during recovery from anesthesia in adult patients who have undergone one of the rhinological surgeries (septoplasty, rhinoseptoplasty or functional endoscopic sinus surgery).
Patients aged 18-65, ASA classification I-II will be anesthetized with balanced anesthesia maintained with sevoflurane and will be randomized into two groups. The first group will receive remimazolam before anesthesia, while the second will receive normal saline solution.
The main outcome of the study will be the presence/absence of delirium during anesthesia recovery, while the secondary outcome will be the postoperative pain level, the length of stay in the recovery room, the presence of unwanted events in the recovery room, and the presence of postoperative mood changes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Remimazolam 20 MG Injection [Byfavo] |
| 2 | Placebo comparator | Drug: NaCl 0.9% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for rhinoplasty, rhinoseptoplasty or FESS
- ASA I or II
Key exclusion criteria (2 listed)
- pregnancy
- patients treated with psychiatric medication (in the time of operation or 6 months prior to operation)
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 |
|---|---|---|
| Remimazolam 20 MG Injection [Byfavo]Remimazolam 0.1 mg/kg intravenous injection | Drug | 1 |
| NaCl 0.9%NaCl 0.9% 0.04 mL/kg | Drug | 2 |
Primary outcome
Richmond agitation sedation scale
Time frame: Immediately after extubation and every five minutes after that for half hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Derived from this study: PubMed 41892844Prizmic G, Peris F, Jozeljic Pesic M, Mitar AM, Bego A, Perkovic SP, Stojanovic Stipic S. Remimazolam Bolus Prevents Emergence Agitation After Rhinologic Surgery: A Randomized, Triple-Blind, Controlled Trial. Med Sci (Basel). 2026 Mar 10;14(1):129. doi: 10.3390/medsci14010129.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Remimazolam 20 MG Injection [Byfavo] and NaCl 0.9% in people with Remimazolam and Emergence Delirium, run by University Hospital of Split at 1 site in Croatia.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 3 May 2024. 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 Croatia. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Grgur Prižmić (+385994213808, gregorio.prizmic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Richmond agitation sedation scale (time frame: Immediately after extubation and every five minutes after that for half hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06398275, which also lists 1 linked publication.
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 3 May 2024.