RemimazolamPhase 4NCT07675850
Efficacy and Safety of Eleveld PK/PD Model-based Dosing During General Anesthesia
A Phase 4 study testing Eleveld model-guided dosing and Standard weight-based label dosing in people with Remimazolam and Pharmacokinetics and Pharmacodynamics, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The goal of this randomized, controlled clinical trial is to evaluate the efficacy, safety, and recovery profile of an individualized, Eleveld pharmacokinetic/pharmacodynamic model-guided dosing strategy for remimazolam in adult patients undergoing elective non-cardiac surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Remimazolam, Pharmacokinetics and Pharmacodynamics
- What is being tested?
- Eleveld model-guided dosing and Standard weight-based label dosing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jul 2026to 31 May 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 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 19 to 79 years undergoing elective non-cardiac surgery expected to last 60 minutes or longer under general anesthesia with endotracheal intubation
Who cannot join
- Emergency surgery
- Surgery requiring evoked potential (EP) monitoring
- Chronic benzodiazepine users
- Body Mass Index (BMI) ≥ 35 kg/㎡
- Chronic kidney disease
- Hepatic dysfunction or chronic liver disease
Show all 10Show fewer
- Contraindication or history of hypersensitivity to remimazolam
- American Society of Anesthesiologists (ASA) physical status ≥ IV
- Pregnant women
- Contraindication or history of hypersensitivity to flumazenil
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, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Jongno-gu, 03080
Seokha Yoo, +82-2-2072-2467, muroki85@snu.ac.kr
About this study
Official title: Comparison of Efficacy and Safety Between Eleveld PK/PD Model-based Dosing and Standard Dosing During General Anesthesia
The goal of this randomized, controlled clinical trial is to evaluate the efficacy, safety, and recovery profile of an individualized, Eleveld pharmacokinetic/pharmacodynamic model-guided dosing strategy for remimazolam in adult patients undergoing elective non-cardiac surgery under general anesthesia.
The main questions it aims to answer are:
Read more
Does Eleveld model-guided customized dosing significantly reduce the eye-opening time at the end of surgery compared to standard weight-based dosing?
Can the Eleveld model-guided approach prevent relative drug accumulation and delayed emergence while maintaining an adequate depth of anesthesia and comparable hemodynamic stability?
Researchers will compare the Experimental Group (Eleveld model-guided dosing) to the Control Group (Standard weight-based label dosing) to see if preemptive dose optimization based on individual patient covariates effectively reduces the total drug consumption, frequency of rescue flumazenil administration, and emergence time.
Participants will:
- Be randomly assigned to receive remimazolam for the induction and maintenance of general anesthesia according to either the Eleveld model-guided customized regimen or the standard weight-based regimen.
- Have their depth of anesthesia continuously monitored using a Bispectral Index (BIS) sensor.
- Be assessed for the primary outcome (time to eye-opening upon verbal command after discontinuation of anesthetics) and secondary outcomes, including total drug consumption, hemodynamic stability, and postoperative complications (e.g., re-sedation, delirium, PONV).
- Conditions
- Remimazolam, Pharmacokinetics and Pharmacodynamics
- Being tested
- Eleveld model-guided dosing, Standard weight-based label dosing
- Keywords
- Remimazolam, general anesthesia, pharmacokinetics and pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eleveld model-guided dosingDrug
Eleveld PK/PD model-guided dosing via a web-based calculator
Standard weight-based label dosingDrug
Induction at 9 mg/kg/h and maintenance at 1-2 mg/kg/h
| Study group | Role | What they receive |
|---|---|---|
| Eleveld model-guided dosing | Experimental | Dosage calculated with Eleveld PK/PD model Receives: Drug: Eleveld model-guided dosing |
| Standard weight-based label dosing | Active comparator | Loading with 9 mg/kg/h until loss of consciousness, then maintenance with 1-2 mg/kg/h Receives: Drug: Standard weight-based label dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye-Opening Time, EOT
Measured: Time from the discontinuation of remimazolam to eye-opening upon verbal command (min), up to 1h
Secondary outcomes (20)
Time to loss of consciousness (LOC)
Measured: Time from the start of remimazolam administration to loss of consciousness (min), up to 1h
Intraoperative Bispectral Index (BIS) values
Measured: Perioperative/Periprocedural
Incidence of intraoperative bradycardia (heart rate < 45 bpm)
Measured: Perioperative/Periprocedural
Incidence of intraoperative tachycardia (heart rate > 110)
Measured: Perioperative/Periprocedural
Incidence of intraoperative hypotension (mean blood pressure < 65 mmHg)
Measured: Perioperative/Periprocedural
Incidence of intraoperative hypertension (SBP > 140 mmHg)
Measured: Perioperative/Periprocedural
Total dose of intraoperative remimazolam (mg)
Measured: Perioperative/Periprocedural
Total dose of intraoperative remifentanil (㎍)
Measured: Perioperative/Periprocedural
Total dose(s) of intraoperative vasopressor(s)
Ephedrine (mg)
Measured: Perioperative/Periprocedural
Extubation time (min)
Measured: Time from the discontinuation of remimazolam to the removal of the endotracheal tube, up to 1h
Incidence of flumazenil administration
Measured: From discontinuation of remimazolam to patient discharge from the operating room, up to 1h
Incidence of rescue sevoflurane use
Measured: Perioperative/Periprocedural
Incidence of oxygen supplementation in the Post-Anesthesia Care Unit (PACU)
Measured: Perioperative/Periprocedural, on the day of surgery
Incidence of postoperative delirium
Measured: Perioperative/Periprocedural, up to 1 week
Incidence of postoperative nausea and vomiting (PONV)
Measured: Perioperative/Periprocedural, up to 1 week
Length of stay in the PACU (min)
Measured: Perioperative/Periprocedural, on the day of surgery
Incidence of re-sedation
Drop in the Modified Observer's Assessment of Alertness/Sedation [MOAA/S] score to 3 or lower during the PACU stay
Measured: Perioperative/Periprocedural, on the day of surgery
Incidence of intraoperative awareness
assessed using the Modified Brice Questionnaire
Measured: Perioperative/Periprocedural
Total dose(s) of intraoperative vasopressor(s)
phenylephrine (㎍)
Measured: Perioperative/Periprocedural
Total dose(s) of intraoperative vasopressor(s)
norepinephrine (㎍)
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start5 Jul 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion31 May 2027 (estimated)
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.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hana Pharm Co., Ltd.
- Responsible party
- Principal investigator, Hansol Kim, MD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675850
- Sponsor's protocol ID
- 2602-094-1720
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety Between Eleveld PK/PD Model-based Dosing and Standard Dosing During General Anesthesia
- ClinicalTrials.gov ID
- NCT07675850
- Acronym / sponsor ID
- 2602-094-1720
- Conditions
- Remimazolam, Pharmacokinetics and Pharmacodynamics
- Keywords
- Remimazolam, general anesthesia, pharmacokinetics and pharmacodynamics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Hana Pharm Co., Ltd.
- Study start
- 5 Jul 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 30 Jun 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 goal of this randomized, controlled clinical trial is to evaluate the efficacy, safety, and recovery profile of an individualized, Eleveld pharmacokinetic/pharmacodynamic model-guided dosing strategy for remimazolam in adult patients undergoing elective non-cardiac surgery under general anesthesia.
The main questions it aims to answer are:
Does Eleveld model-guided customized dosing significantly reduce the eye-opening time at the end of surgery compared to standard weight-based dosing?
Can the Eleveld model-guided approach prevent relative drug accumulation and delayed emergence while maintaining an adequate depth of anesthesia and comparable hemodynamic stability?
Researchers will compare the Experimental Group (Eleveld model-guided dosing) to the Control Group (Standard weight-based label dosing) to see if preemptive dose optimization based on individual patient covariates effectively reduces the total drug consumption, frequency of rescue flumazenil administration, and emergence time.
Participants will:
- Be randomly assigned to receive remimazolam for the induction and maintenance of general anesthesia according to either the Eleveld model-guided customized regimen or the standard weight-based regimen.
- Have their depth of anesthesia continuously monitored using a Bispectral Index (BIS) sensor.
- Be assessed for the primary outcome (time to eye-opening upon verbal command after discontinuation of anesthetics) and secondary outcomes, including total drug consumption, hemodynamic stability, and postoperative complications (e.g., re-sedation, delirium, PONV).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eleveld model-guided dosing | Experimental | Drug: Eleveld model-guided dosingDosage calculated with Eleveld PK/PD model |
| Standard weight-based label dosing | Active comparator | Drug: Standard weight-based label dosingLoading with 9 mg/kg/h until loss of consciousness, then maintenance with 1-2 mg/kg/h |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 19 to 79 years undergoing elective non-cardiac surgery expected to last 60 minutes or longer under general anesthesia with endotracheal intubation
Key exclusion criteria (10 listed)
- Emergency surgery
- Surgery requiring evoked potential (EP) monitoring
- Chronic benzodiazepine users
- Body Mass Index (BMI) ≥ 35 kg/㎡
- Chronic kidney disease
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 |
|---|---|---|
| Eleveld model-guided dosingEleveld PK/PD model-guided dosing via a web-based calculator | Drug | Eleveld model-guided dosing |
| Standard weight-based label dosingInduction at 9 mg/kg/h and maintenance at 1-2 mg/kg/h | Drug | Standard weight-based label dosing |
Primary outcome
Eye-Opening Time, EOT
Time frame: Time from the discontinuation of remimazolam to eye-opening upon verbal command (min), up to 1h
20 secondary outcomes
Time to loss of consciousness (LOC)
Time frame: Time from the start of remimazolam administration to loss of consciousness (min), up to 1h
Intraoperative Bispectral Index (BIS) values
Time frame: Perioperative/Periprocedural
Incidence of intraoperative bradycardia (heart rate < 45 bpm)
Time frame: Perioperative/Periprocedural
Incidence of intraoperative tachycardia (heart rate > 110)
Time frame: Perioperative/Periprocedural
Incidence of intraoperative hypotension (mean blood pressure < 65 mmHg)
Time frame: Perioperative/Periprocedural
Incidence of intraoperative hypertension (SBP > 140 mmHg)
Time frame: Perioperative/Periprocedural
Total dose of intraoperative remimazolam (mg)
Time frame: Perioperative/Periprocedural
Total dose of intraoperative remifentanil (㎍)
Time frame: Perioperative/Periprocedural
Total dose(s) of intraoperative vasopressor(s)
Time frame: Perioperative/Periprocedural
Extubation time (min)
Time frame: Time from the discontinuation of remimazolam to the removal of the endotracheal tube, up to 1h
Incidence of flumazenil administration
Time frame: From discontinuation of remimazolam to patient discharge from the operating room, up to 1h
Incidence of rescue sevoflurane use
Time frame: Perioperative/Periprocedural
Incidence of oxygen supplementation in the Post-Anesthesia Care Unit (PACU)
Time frame: Perioperative/Periprocedural, on the day of surgery
Incidence of postoperative delirium
Time frame: Perioperative/Periprocedural, up to 1 week
Incidence of postoperative nausea and vomiting (PONV)
Time frame: Perioperative/Periprocedural, up to 1 week
Length of stay in the PACU (min)
Time frame: Perioperative/Periprocedural, on the day of surgery
Incidence of re-sedation
Time frame: Perioperative/Periprocedural, on the day of surgery
Incidence of intraoperative awareness
Time frame: Perioperative/Periprocedural
Total dose(s) of intraoperative vasopressor(s)
Time frame: Perioperative/Periprocedural
Total dose(s) of intraoperative vasopressor(s)
Time frame: Perioperative/Periprocedural
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 29 Sep 2026.
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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 Eleveld model-guided dosing and Standard weight-based label dosing in people with Remimazolam and Pharmacokinetics and Pharmacodynamics, run by Seoul National University Hospital 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 1 inclusion and 10 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 29 Sep 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 Hansol Kim, M.D. (+82-2-2072-2467, hansolfrkr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eye-Opening Time, EOT (time frame: Time from the discontinuation of remimazolam to eye-opening upon verbal command (min), up to 1h). 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 29 Sep 2026.