Emergence AgitationPhase 4NCT07740655
Low-dose Versus Standard-dose Remimazolam for Prevention of Emergence Agitation After Nasal Surgery
A Phase 4 study testing Remimazolam in people with Emergence Agitation and General Anesthesia, run by Jeju National University School of Medicine at 1 site in South Korea.
Trial summary
Emergence agitation (EA) is a common complication during recovery from sevoflurane anesthesia, particularly after nasal surgery. Although remimazolam 0.1 mg/kg has been shown to reduce the incidence of EA, this dose may produce excessive sedation and increase the risk of intraoperative burst suppression. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Emergence Agitation, General Anesthesia, Nasal Surgical Procedures
- What is being tested?
- Remimazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jul 2026to 31 Jul 2027
- Phase
- Phase 4
- 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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 79 years.
- Scheduled to undergo elective nasal surgery under sevoflurane-based general anesthesia at Jeju National University Hospital.
- Able to provide written informed consent.
Who cannot join
- Contraindications to remimazolam.
- History of allergy or hypersensitivity to benzodiazepines.
- Inability to provide informed consent due to cognitive impairment.
- Preexisting psychiatric disorders.
- History of alcohol or substance abuse.
- Inability to assess the Riker Sedation-Agitation Scale (SAS).
- Body mass index (BMI) > 40 kg/m².
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Jeju National University Hospital
Jeju City, Jeju-do
Seung Eun Song, MD, +82-64-717-2031, ansongse@gmail.com
About this study
Official title: Low-dose Versus Standard-dose Remimazolam for Prevention of Emergence Agitation After Nasal Surgery Under Sevoflurane Anesthesia: A Randomized Double-blind Non-inferiority Trial
Emergence agitation (EA) is a common complication during recovery from sevoflurane anesthesia, particularly after nasal surgery. Although remimazolam 0.1 mg/kg has been shown to reduce the incidence of EA, this dose may produce excessive sedation and increase the risk of intraoperative burst suppression.
This randomized, double-blind, non-inferiority trial will compare low-dose remimazolam (0.03 mg/kg) with the standard dose (0.1 mg/kg) administered at the end of surgery in adult patients undergoing nasal surgery under sevoflurane anesthesia. The primary objective is to determine whether low-dose remimazolam is non-inferior to the standard dose in preventing emergence agitation. Secondary outcomes include burst suppression, recovery profiles, and safety outcomes.
Read the detailed description
Emergence agitation (EA) is characterized by confusion, agitation, and non-purposeful movements during recovery from general anesthesia. In adult patients undergoing nasal surgery with sevoflurane anesthesia, EA occurs frequently and may result in self-injury, accidental removal of medical devices, postoperative bleeding, prolonged recovery, and increased healthcare burden.
Remimazolam is an ultra-short-acting benzodiazepine that is rapidly metabolized by tissue esterases and can be antagonized with flumazenil. Previous studies have demonstrated that intravenous administration of remimazolam 0.1 mg/kg at the end of surgery reduces the incidence of EA after nasal surgery. However, this dose may produce deeper-than-necessary sedation and increase the occurrence of burst suppression, which has been associated with postoperative delirium.
The present study aims to evaluate whether a lower dose of remimazolam (0.03 mg/kg), corresponding to the supplemental dose commonly used for procedural sedation, can preserve the preventive effect on EA while reducing excessive electroencephalographic suppression and improving recovery characteristics.
This is a prospective, randomized, double-blind, non-inferiority trial conducted at Jeju National University Hospital. Adult patients scheduled for nasal surgery under sevoflurane anesthesia will be randomly assigned in a 1:1 ratio to receive either remimazolam 0.03 mg/kg or remimazolam 0.1 mg/kg immediately after discontinuation of sevoflurane at the end of surgery.
The primary outcome is the incidence of emergence agitation within 15 minutes after extubation, defined as a Riker Sedation-Agitation Scale (SAS) score of 5 or greater. Secondary outcomes include the incidence and duration of burst suppression assessed using the SedLine monitor, Patient State Index (PSi), extubation time, post-anesthesia care unit (PACU) length of stay, and safety outcomes including hypoxemia, hypotension, flumazenil administration, and other adverse events.
- Being tested
- Remimazolam
- Keywords
- Remimazolam, Emergence Agitation Sevoflurane, Nasal Surgery, Non-inferiority Trial
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemimazolamDrug
Remimazolam will be administered intravenously immediately after discontinuation of sevoflurane at the end of surgery. Participants will receive either 0.03 mg/kg or 0.1 mg/kg according to randomized treatment allocation.
| Study group | Role | What they receive |
|---|---|---|
| Standard-dose Remimazolam | Experimental | Participants will receive remimazolam 0.1 mg/kg intravenously immediately after discontinuation of sevoflurane at the end of nasal surgery under general anesthesia. Receives: Drug: Remimazolam |
| Low-dose Remimazolam | Experimental | Participants will receive remimazolam 0.03 mg/kg intravenously immediately after discontinuation of sevoflurane at the end of nasal surgery under general anesthesia. Receives: Drug: Remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of emergence agitation
The incidence of emergence agitation within 15 minutes after extubation, defined as a Riker Sedation-Agitation Scale (SAS) score of 5 or greater.
Measured: Within 15 minutes after extubation
Secondary outcomes (3)
Incidence of burst suppression
Burst suppression is defined as a suppression ratio greater than 0% lasting for at least 1 minute or occurring repeatedly between study drug administration and extubation.
Measured: From study drug administration until extubation(up to 30 minutes)
Duration of burst suppression
Cumulative duration of suppression ratio greater than 0% measured using the SedLine monitor.
Measured: From study drug administration until extubation(up to 30 minutes)
Lowest Patient State Index (PSI)
Lowest Patient State Index recorded after study drug administration.
Measured: From study drug administration until extubation(up to 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start24 Jul 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence AgitationStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeju National University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung Eun Song, Jeju National University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740655
- Sponsor's protocol ID
- JEJUNUH 2026-06-005-001
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 31 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 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Versus Standard-dose Remimazolam for Prevention of Emergence Agitation After Nasal Surgery Under Sevoflurane Anesthesia: A Randomized Double-blind Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT07740655
- Acronym / sponsor ID
- JEJUNUH 2026-06-005-001
- Keywords
- Remimazolam, Emergence Agitation Sevoflurane, Nasal Surgery, Non-inferiority Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Jeju National University School of MedicineUniversity, hospital or other
- Study start
- 24 Jul 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 31 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.
Emergence agitation (EA) is a common complication during recovery from sevoflurane anesthesia, particularly after nasal surgery. Although remimazolam 0.1 mg/kg has been shown to reduce the incidence of EA, this dose may produce excessive sedation and increase the risk of intraoperative burst suppression.
This randomized, double-blind, non-inferiority trial will compare low-dose remimazolam (0.03 mg/kg) with the standard dose (0.1 mg/kg) administered at the end of surgery in adult patients undergoing nasal surgery under sevoflurane anesthesia. The primary objective is to determine whether low-dose remimazolam is non-inferior to the standard dose in preventing emergence agitation. Secondary outcomes include burst suppression, recovery profiles, and safety outcomes.
Detailed description
Emergence agitation (EA) is characterized by confusion, agitation, and non-purposeful movements during recovery from general anesthesia. In adult patients undergoing nasal surgery with sevoflurane anesthesia, EA occurs frequently and may result in self-injury, accidental removal of medical devices, postoperative bleeding, prolonged recovery, and increased healthcare burden.
Remimazolam is an ultra-short-acting benzodiazepine that is rapidly metabolized by tissue esterases and can be antagonized with flumazenil. Previous studies have demonstrated that intravenous administration of remimazolam 0.1 mg/kg at the end of surgery reduces the incidence of EA after nasal surgery. However, this dose may produce deeper-than-necessary sedation and increase the occurrence of burst suppression, which has been associated with postoperative delirium.
The present study aims to evaluate whether a lower dose of remimazolam (0.03 mg/kg), corresponding to the supplemental dose commonly used for procedural sedation, can preserve the preventive effect on EA while reducing excessive electroencephalographic suppression and improving recovery characteristics.
This is a prospective, randomized, double-blind, non-inferiority trial conducted at Jeju National University Hospital. Adult patients scheduled for nasal surgery under sevoflurane anesthesia will be randomly assigned in a 1:1 ratio to receive either remimazolam 0.03 mg/kg or remimazolam 0.1 mg/kg immediately after discontinuation of sevoflurane at the end of surgery.
The primary outcome is the incidence of emergence agitation within 15 minutes after extubation, defined as a Riker Sedation-Agitation Scale (SAS) score of 5 or greater. Secondary outcomes include the incidence and duration of burst suppression assessed using the SedLine monitor, Patient State Index (PSi), extubation time, post-anesthesia care unit (PACU) length of stay, and safety outcomes including hypoxemia, hypotension, flumazenil administration, and other adverse events.
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 |
|---|---|---|
| Standard-dose Remimazolam | Experimental | Drug: RemimazolamParticipants will receive remimazolam 0.1 mg/kg intravenously immediately after discontinuation of sevoflurane at the end of nasal surgery under general anesthesia. |
| Low-dose Remimazolam | Experimental | Drug: RemimazolamParticipants will receive remimazolam 0.03 mg/kg intravenously immediately after discontinuation of sevoflurane at the end of nasal surgery under general anesthesia. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 to 79 years.
- Scheduled to undergo elective nasal surgery under sevoflurane-based general anesthesia at Jeju National University Hospital.
- Able to provide written informed consent.
Key exclusion criteria (7 listed)
- Contraindications to remimazolam.
- History of allergy or hypersensitivity to benzodiazepines.
- Inability to provide informed consent due to cognitive impairment.
- Preexisting psychiatric disorders.
- History of alcohol or substance abuse.
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 |
|---|---|---|
| RemimazolamRemimazolam will be administered intravenously immediately after discontinuation of sevoflurane at the end of surgery. Participants will receive either 0.03 mg/kg or 0.1 mg/kg according to randomized treatment allocation. | Drug | Low-dose Remimazolam, Standard-dose Remimazolam |
Primary outcome
Incidence of emergence agitation
Time frame: Within 15 minutes after extubation
The incidence of emergence agitation within 15 minutes after extubation, defined as a Riker Sedation-Agitation Scale (SAS) score of 5 or greater.
3 secondary outcomes
Incidence of burst suppression
Time frame: From study drug administration until extubation(up to 30 minutes)
Duration of burst suppression
Time frame: From study drug administration until extubation(up to 30 minutes)
Lowest Patient State Index (PSI)
Time frame: From study drug administration until extubation(up to 30 minutes)
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 31 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remimazolam in people with Emergence Agitation and General Anesthesia, run by Jeju National University School of Medicine at 1 site in South Korea.
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 7 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: opening soon, as of the sponsor's last update on 31 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Seung Eun Song, MD (+82-64-717-2031, ansongse@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of emergence agitation (time frame: Within 15 minutes after extubation). 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 31 Jul 2026.