None listed
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| pharmacokinetic parameter (volume of distribution, clearance, Emax) | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse event | — |
Countries
Korea, Republic of
Contacts
Asan Medical Center