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NCT Number: NCT07675850

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

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).

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Key information

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eleveld model-guided dosing

Drug

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

Standard weight-based label dosing

Drug

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

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

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

    Time frame: Perioperative/Periprocedural

  6. Incidence of intraoperative hypertension (SBP > 140 mmHg)

    Time frame: Perioperative/Periprocedural

  7. Total dose of intraoperative remimazolam (mg)

    Time frame: Perioperative/Periprocedural

  8. Total dose of intraoperative remifentanil (㎍)

    Time frame: Perioperative/Periprocedural

  9. Total dose(s) of intraoperative vasopressor(s)

    Time frame: Perioperative/Periprocedural

    Ephedrine (mg)

  10. Extubation time (min)

    Time frame: Time from the discontinuation of remimazolam to the removal of the endotracheal tube, up to 1h

  11. Incidence of flumazenil administration

    Time frame: From discontinuation of remimazolam to patient discharge from the operating room, up to 1h

  12. Incidence of rescue sevoflurane use

    Time frame: Perioperative/Periprocedural

  13. Incidence of oxygen supplementation in the Post-Anesthesia Care Unit (PACU)

    Time frame: Perioperative/Periprocedural, on the day of surgery

  14. Incidence of postoperative delirium

    Time frame: Perioperative/Periprocedural, up to 1 week

  15. Incidence of postoperative nausea and vomiting (PONV)

    Time frame: Perioperative/Periprocedural, up to 1 week

  16. Length of stay in the PACU (min)

    Time frame: Perioperative/Periprocedural, on the day of surgery

  17. Incidence of re-sedation

    Time frame: Perioperative/Periprocedural, on the day of surgery

    Drop in the Modified Observer's Assessment of Alertness/Sedation [MOAA/S] score to 3 or lower during the PACU stay

  18. Incidence of intraoperative awareness

    Time frame: Perioperative/Periprocedural

    assessed using the Modified Brice Questionnaire

  19. Total dose(s) of intraoperative vasopressor(s)

    Time frame: Perioperative/Periprocedural

    phenylephrine (㎍)

  20. Total dose(s) of intraoperative vasopressor(s)

    Time frame: Perioperative/Periprocedural

    norepinephrine (㎍)

Study contacts

Contact information is provided by the study sponsor or research team.

Hansol Kim, M.D.

CONTACT

[email protected]

+82-2-2072-2467

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Hana Pharm Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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