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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19-79
SponsorSeoul National University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Patients aged 19 to 79 years undergoing elective non-cardiac surgery expected to last 60 minutes or longer under general anesthesia with endotracheal intubation

Disqualifiers

Emergency surgery

Surgery requiring evoked potential (EP) monitoring

Chronic benzodiazepine users

Body Mass Index (BMI) ≥ 35 kg/㎡

Trial design

Design model

Parallel

Treatments tested in this trial

  • Eleveld model-guided dosing

    Drug

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

  • Standard weight-based label dosing

    Drug

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

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Eleveld model-guided dosingExperimental treatment 1 intervention
Group B: Standard weight-based label dosingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Eye-Opening Time, EOT

Time frame
Time from the discontinuation of remimazolam to eye-opening upon verbal command (min), up to 1h

Secondary outcomes

1

Time to loss of consciousness (LOC)

Time frame
Time from the start of remimazolam administration to loss of consciousness (min), up to 1h
2

Intraoperative Bispectral Index (BIS) values

Time frame
Perioperative/Periprocedural
3

Incidence of intraoperative bradycardia (heart rate < 45 bpm)

Time frame
Perioperative/Periprocedural
4

Incidence of intraoperative tachycardia (heart rate > 110)

Time frame
Perioperative/Periprocedural

Other outcomes

Sponsors and contacts

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Seoul National University Hospital

Lead sponsor

Hana Pharm Co., Ltd.

Collaborator