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Efficacy and Safety of Eleveld PK/PD Model-based Dosing During General Anesthesia

NCT07675850 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-08-25

No results posted yet for this study

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).

Conditions

  • Remimazolam
  • Pharmacokinetics and Pharmacodynamics

Interventions

DRUG

Eleveld model-guided dosing

Eleveld PK/PD model-guided dosing via a web-based calculator

DRUG

Standard weight-based label dosing

Induction at 9 mg/kg/h and maintenance at 1-2 mg/kg/h

Sponsors & Collaborators

  • Hana Pharm Co., Ltd.

    collaborator INDUSTRY

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-30
Primary Completion
2027-04-30
Completion
2027-05-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07675850 on ClinicalTrials.gov