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Development of pharmacokinetic-pharmacodynamic model for the target-controlled infusion of hypnotic agent remimazolam in surgical patients

Development of pharmacokinetic-pharmacodynamic model for the target-controlled infusion of remimazolam in surgical patients

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CRIS
Registry ID
KCT0010288
Enrollment
48
Registered
2025-03-12
Start date
2025-03-10
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Remimazolam is administered according to standard operating protocol: During the induction of anesthesia, remimazolam is administered until loss of consciousness is observed, and during the ma

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adults aged 20 years and older: 16 patients in each age group of 20-40 years, 41-64 years, and 65 years and older Patients scheduled to undergo elective surgery using remimazolam at Asan Medical Center Patients expected to undergo surgeries lasting more than 3 hours that require continuous arterial blood pressure monitoring for medical purposes during general anesthesia Patients classified as American Society of Anesthesiologists (ASA) physical status I-III Patients weighing 40 kg or more Patients who have voluntarily given written consent to participate in this clinical study

Exclusion criteria

Exclusion criteria: Women who are pregnant or breastfeeding Patients with a history of hypersensitivity to remimazolam or formulations containing midazolam and dextran Patients who have taken central nervous system-active drugs (such as ketamine, amphetamine, midazolam, opioids, chlorpromazine, clozapine, olanzapine, risperidone, haloperidol, quetiapine, risperidone, paliperidone, amisulpride, sertindole, etc.) and have not waited at least five times the elimination half-life of each drug Patients who received midazolam or remimazolam within 7 days prior to the consent date Patients with moderate to severe hepatic impairment, specifically those classified as Child-Pugh class B and C Patients with hemoglobin levels below 8 g/dl Other patients deemed unsuitable by the investigator

Design outcomes

Primary

MeasureTime frame
pharmacokinetic parameter (volume of distribution, clearance, Emax)

Secondary

MeasureTime frame
adverse event

Countries

Korea, Republic of

Contacts

Public ContactKyung Mi Kim

Asan Medical Center

sumsonyo@gmail.com+82-2-3010-5631

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026