Pharmacodynamic trial for predicting the effect site concentration of remimazolam at awakening

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031240098

Enrollment

Registered

2024-05-20

Start date

2025-06-19

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Not limited

Interventions

IV bolus remimazolam 3mg (for the patient less than) or 4mg (for the patient 60 kg or more) for an induction of general anesthesia, and assess loss of conciousness using mOAA/S score.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients between 18 and 89 year-old, undergoing general anesthesia for elective surgery at Yokohama City University Hospital (2) Patients who have given written consent to participate this study (3) Patients with GCS score 15

Exclusion criteria

Exclusion criteria: (1) Patients for whom remimazolam and rocuronium are contraindicated in the Japanese package inserts (2) Patients receiving benzodiazepines for >=1 week within 3 months (3) Patients with a history of drug dependence; organic brain disease; pregnant and lactating women (4) American Society of Anesthesiologists physical status is >=3; body mass index >=30 kg/m2 (5) Patients deemed ineligible by the study physician

Design outcomes

Primary

Measure	Time frame
The effect site concentration of remimazolam at awakening	—

Secondary

Measure	Time frame
Values of 1. electroencephalogram monitoring (patient state index, spectral edge frequency) 2. the effect site concentration of remimazolam in the operating room	—

Contacts

Public ContactAyako Tojo

Yokohama City University Hospital

tojo.aya.hy@yokohama-cu.ac.jp+81-45-787-2918

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026