NCT07675850 Efficacy and Safety of Eleveld PK/PD Model-based Dosing During General Anesthesia
| NCT ID | NCT07675850 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Seoul National University Hospital |
| Condition | Remimazolam |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2026-07-05 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 68 participants in total. It began in 2026-07-05 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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).
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07675850 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 79 Years, studying Remimazolam. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07675850 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07675850 currently recruiting?
Yes, NCT07675850 is actively recruiting participants. Contact the research team at hansolfrkr@gmail.com for enrollment information.
Where is the NCT07675850 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07675850 clinical trial?
NCT07675850 is sponsored by Seoul National University Hospital. The trial plans to enroll 68 participants.