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

NCT07675850 | Not Yet Recruiting Phase 4

• 1 other identifier: 2602-094-1720
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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).

Conditions

Remimazolam; Pharmacokinetics and Pharmacodynamics

Keywords

Remimazolam; general anesthesia; pharmacokinetics and pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Eye-Opening Time, EOT

  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)

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

• Intraoperative Bispectral Index (BIS) values

  Perioperative/Periprocedural

• Incidence of intraoperative bradycardia (heart rate < 45 bpm)

  Perioperative/Periprocedural

• Incidence of intraoperative tachycardia (heart rate > 110)

  Perioperative/Periprocedural

• Incidence of intraoperative hypotension (mean blood pressure < 65 mmHg)

  Perioperative/Periprocedural

Study Arms (2)

Eleveld model-guided dosing

EXPERIMENTAL

Drug: Eleveld model-guided dosing

Standard weight-based label dosing

ACTIVE COMPARATOR

Drug: Standard weight-based label dosing

Interventions

Eleveld model-guided dosing DRUG

Eleveld model-guided dosing via a validated web-based calculator

Eleveld model-guided dosing

Standard weight-based label dosing DRUG

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

Standard weight-based label dosing

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Hana Pharm Co., Ltd.: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

Central Study Contacts

Hansol Kim, M.D.

CONTACT

+82-2-2072-2467; hansolfrkr@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 30, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

KR (1)