Health TrialsbyHealthPanel

Response Surface Modeling of Remimazolam and Sevoflurane

ConditionLaparoscopic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorPusan National University Yangsan Hospital

About this trial

This prospective randomized open-label study aims to investigate the pharmacodynamic interaction between remimazolam and sevoflurane during general anesthesia using response surface modeling. Although remimazolam has favorable hemodynamic stability compared with propofol, its hypnotic effect may be less predictable and poorly correlated with conventional sedation monitoring indices such as the bispectral index (BIS). In clinical practice, remimazolam and sevoflurane are often combined during induction and maintenance of anesthesia; however, the optimal interaction between these agents remains unclear.

This study will evaluate whether the interaction between remimazolam and sevoflurane is synergistic, additive, or infra-additive using two representative response surface interaction models: the Minto model and the Greco model. BIS values and predicted effect-site concentrations will be analyzed using NONMEM software.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 20 to 80 years

Scheduled for elective surgery under general anesthesia at Pusan National University Yangsan Hospital

American Society of Anesthesiologists (ASA) physical status I or II

Able to provide written informed consent

Disqualifiers

Known allergy to remimazolam or sevoflurane

Renal, hepatic, neuromuscular, or neurological disease

Use of medications affecting the central nervous system

Chronic psychoactive drug use

Trial design

Design model

Single group

Treatments tested in this trial

  • Remimazolam (Byfavo)

    Drug

    Remimazolam will be administered at infusion rates ranging from 0 to 6 mg/kg/h using an infusion pump with pharmacokinetic simulation software.

  • Sevoflurane (Volatile Anesthetic)

    Drug

    Sevoflurane will be administered by inhalation with targeted end-tidal concentrations between 0 and 2 vol%.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Remimazolam and Sevoflurane Combination During Anesthetic InductionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Interaction coefficient (α) between remimazolam and sevoflurane derived from the Minto response surface model

The interaction coefficient (α) describing the pharmacodynamic interaction between remimazolam effect-site concentration and end-tidal sevoflurane concentration will be estimated using the Minto response surface model based on BIS values collected during anesthetic induction.

Time frame
During anesthetic induction
2

Interaction parameter between remimazolam and sevoflurane derived from the Greco response surface model

The pharmacodynamic interaction parameter describing the interaction between remimazolam effect-site concentration and end-tidal sevoflurane concentration will be estimated using the Greco response surface model based on BIS values collected during anesthetic induction.

Time frame
During anesthetic induction

Secondary outcomes

1

BIS response according to hypnotic combinations

Bispectral Index (BIS) values will be continuously recorded during anesthetic induction according to predefined combinations of remimazolam effect-site concentration and end-tidal sevoflurane concentration. The BIS is a processed electroencephalographic monitoring scale ranging from 0 to 100, where lower values indicate deeper levels of hypnosis and higher values indicate lighter levels of sedation or consciousness.

Time frame
During anesthetic induction
2

Loss of consciousness (LOC)

Time to loss of consciousness during induction

Time frame
During anesthetic induction
3

Recovery of consciousness (ROC)

Time to recovery of consciousness

Time frame
During emergence from anesthesia
4

Heart rate

Heart rate (beats per minute) will be recorded at 5-minute intervals during the intraoperative period.

Time frame
Intraoperative period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pusan National University Yangsan Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now