RemimazolamPhase 1NCT07704437
Remimazolam for Emergence Delirium Prevention in Children Undergoing Tonsillectomy
A Phase 1 study testing Remimazolam 20 MG Injection [Byfavo] and NaCl (0,9%) in people with Remimazolam and Tonsillectomy, run by University Hospital of Split at 1 site in Croatia.
Trial summary
The aim of this study is to confirm the effectiveness of remimazolam in preventing delirium during emergence from anesthesia in children who will undergo elective procedures of tonsillectomy, adenotonsillectomy or adenoidectomy, aged 3-12 years, American Society of Anesthesiologists (ASA) physical status I. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Remimazolam, Tonsillectomy, Emergence Delirium
- 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
- 110 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Apr 2024to 5 May 2026
- Phase
- Phase 1
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I
- Children undergoing scheduled tonsillectomy/adenoidectomy or combined procedure
Who cannot join
- American Society of Anesthesiologists (ASA) physical status > 1
- Known hypersensitivity to remimazolam or other benzodiazepines
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to confirm the effectiveness of remimazolam in preventing delirium during emergence from anesthesia in children who will undergo elective procedures of tonsillectomy, adenotonsillectomy or adenoidectomy, aged 3-12 years, American Society of Anesthesiologists (ASA) physical status I. Children will be anesthetized with balanced anesthesia, maintained with sevoflurane and will be randomized in two groups. The first group will receive remimazolam before anesthesia, while the second will receive normal saline, both intravenously.
The main outcome of the study will be the presence/absence of delirium during anesthesia recovery, while the secondary outcome will be postoperative pain level, length of stay in the recovery room, presence of unwanted events in the recovery room, presence of postoperative mood changes, as well as parental satisfaction.
Read the detailed description
The aim of this study is to confirm the effectiveness of remimazolam in preventing delirium during emergence from anesthesia in children who will undergo elective procedures of tonsillectomy, adenotonsillectomy or adenoidectomy, aged 3-12 years, ASA classification I. Children will be anesthetized with balanced anesthesia, maintained with sevoflurane and will be randomized in two groups. The first group will receive remimazolam before anesthesia, while the second will receive normal saline, both intravenously.
The main outcome of the study will be the presence/absence of delirium during anesthesia recovery, while the secondary outcome will be postoperative pain level, length of stay in the recovery room, presence of unwanted events in the recovery room, presence of postoperative mood changes, as well as parental satisfaction.
- Conditions
- Remimazolam, Tonsillectomy, Emergence Delirium
- 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 |
|---|---|---|
| Remimazolam | Experimental | Not described Receives: Drug: Remimazolam 20 MG Injection [Byfavo] |
| NaCl 0,9 % | 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.
PAED (pediatric anesthesia emergence delirium scale)
The PAED scale consists of 5 criteria that are scored using a 5-point scale. A score greater than 10 (or greater than 12) represents emergence delirium.
Measured: Perioperative - immediately after extubation and 3 times after that every 10 minutes
Secondary outcomes (1)
FLACC ( Face, Legs, Activity, Cry, Consolability scale for assessing pain)
The scale is scored from 0 to 10, where 0 represents no pain and higher scores indicate greater pain.
Measured: Perioperative - immediately after extubation and 3 times after that every 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Apr 2024
- Primary completion15 Jul 2025
- Study completion5 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Split
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Peris, University Hospital of Split
- Investigators
- Filip Peris, Principal investigator, University Hospital of Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704437
- Sponsor's protocol ID
- 520-03/24-01/13
- Status last verified
- Jan 2024
- First submitted
- 7 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remimazolam for Emergence Delirium Prevention in Children Undergoing Tonsillectomy
- ClinicalTrials.gov ID
- NCT07704437
- Acronym / sponsor ID
- 520-03/24-01/13
- Conditions
- Remimazolam, Tonsillectomy, Emergence Delirium
- Keywords
- Remimazolam
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University Hospital of SplitUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 15 Jul 2026 (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 study is to confirm the effectiveness of remimazolam in preventing delirium during emergence from anesthesia in children who will undergo elective procedures of tonsillectomy, adenotonsillectomy or adenoidectomy, aged 3-12 years, American Society of Anesthesiologists (ASA) physical status I. Children will be anesthetized with balanced anesthesia, maintained with sevoflurane and will be randomized in two groups. The first group will receive remimazolam before anesthesia, while the second will receive normal saline, both intravenously.
The main outcome of the study will be the presence/absence of delirium during anesthesia recovery, while the secondary outcome will be postoperative pain level, length of stay in the recovery room, presence of unwanted events in the recovery room, presence of postoperative mood changes, as well as parental satisfaction.
Detailed description
The aim of this study is to confirm the effectiveness of remimazolam in preventing delirium during emergence from anesthesia in children who will undergo elective procedures of tonsillectomy, adenotonsillectomy or adenoidectomy, aged 3-12 years, ASA classification I. Children will be anesthetized with balanced anesthesia, maintained with sevoflurane and will be randomized in two groups. The first group will receive remimazolam before anesthesia, while the second will receive normal saline, both intravenously.
The main outcome of the study will be the presence/absence of delirium during anesthesia recovery, while the secondary outcome will be postoperative pain level, length of stay in the recovery room, presence of unwanted events in the recovery room, presence of postoperative mood changes, as well as parental satisfaction.
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 |
|---|---|---|
| Remimazolam | Experimental | Drug: Remimazolam 20 MG Injection [Byfavo] |
| NaCl 0,9 % | Placebo comparator | Drug: NaCl (0,9%) |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status I
- Children undergoing scheduled tonsillectomy/adenoidectomy or combined procedure
Key exclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status > 1
- Known hypersensitivity to remimazolam or other benzodiazepines
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 | Remimazolam |
| NaCl (0,9%)NaCl 0.9% 0.04 mL/kg | Drug | NaCl 0,9 % |
Primary outcome
PAED (pediatric anesthesia emergence delirium scale)
Time frame: Perioperative - immediately after extubation and 3 times after that every 10 minutes
The PAED scale consists of 5 criteria that are scored using a 5-point scale. A score greater than 10 (or greater than 12) represents emergence delirium.
1 secondary outcome
FLACC ( Face, Legs, Activity, Cry, Consolability scale for assessing pain)
Time frame: Perioperative - immediately after extubation and 3 times after that every 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Filip Peris principal investigator
University Hospital of Split
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Remimazolam 20 MG Injection [Byfavo] and NaCl (0,9%) in people with Remimazolam and Tonsillectomy, 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: finished, as of the sponsor's last update on 15 Jul 2026. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAED (pediatric anesthesia emergence delirium scale) (time frame: Perioperative - immediately after extubation and 3 times after that every 10 minutes). 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 15 Jul 2026.