Personalized dosing of remimazolam during general anesthesia using the Eleveld PK/PD model
Official title: Comparison of Efficacy and Safety Between Eleveld PK/PD Model-based Dosing and Standard Dosing During General Anesthesia
Run by Seoul National University Hospital · NCT07675850 · Data updated 2026-11-12
This trial tests whether a model-guided dosing strategy for remimazolam, tailored to each patient, can improve recovery after general anesthesia in adults undergoing non-cardiac surgery compared with standard dosing.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years to 79 Years |
| Sex | All |
| Enrollment | 68 (estimated) |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul, Jongno-gu) |
| Status | Recruiting |
| Started | July 5, 2026 |
| Main results expected | April 30, 2027 |
| Study ends | May 31, 2027 |
| Registry record updated | September 29, 2026 |
| Trial ID | NCT07675850 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 19–79 undergoing elective non-cardiac surgery of at least 60 minutes under general anesthesia, without significant organ dysfunction or benzodiazepine contraindications.
✕Probably not a fit
Patients with severe hepatic or renal impairment, obesity (BMI ≥ 35), or other exclusion criteria may not benefit from model-guided dosing.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, controlled trial compares an individualized dosing approach for remimazolam based on the Eleveld PK/PD model with conventional weight-based dosing in adults having elective non-cardiac surgery under general anesthesia. The study aims to see if model-guided dosing reduces eye-opening time at the end of surgery, prevents drug accumulation and delayed emergence, and maintains stable anesthesia depth and hemodynamics. Participants are adults 19 to 79 years old without major organ disease or other contraindications, and the trial is conducted at Seoul National University Hospital with Hana Pharm Co. as a collaborator. Primary outcomes include total remimazolam use, need for rescue flumazenil, and emergence profile. Safety and recovery metrics are collected to assess efficacy and tolerability.
Why it matters
Potential benefit: If successful, patients could experience faster and smoother emergence from anesthesia with less drug use.
How similar studies have gone: Previous pharmacokinetic/pharmacodynamic modeling approaches have shown promise in optimizing anesthetic dosing, but the specific Eleveld model-guided strategy in remimazolam is being evaluated in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 19 to 79 years undergoing elective non-cardiac surgery expected to last 60 minutes or longer under general anesthesia with endotracheal intubation Exclusion Criteria: * 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 * Contraindication or history of hypersensitivity to remimazolam * American Society of Anesthesiologists (ASA) physical status ≥ IV * Pregnant women * Contraindication or history of hypersensitivity to flumazenil
Where it's running
-
Seoul National University Hospital
Seoul, Jongno-gu, South Korea Recruiting
Study contacts
- Study coordinator: Hansol Kim, M.D.
- Email: hansolfrkr@gmail.com
- Phone: +82-2-2072-2467
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.