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

JRCT ID: jRCTs031240098

Registered date:20/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Not limited
• Date of first enrollment: 20/05/2024
• Target sample size: 54
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: The effect site concentration of remimazolam at awakening

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 90age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Tojo Ayako