Electroencephalogramic changes during remimazolam general anesthesia: the relationship between estimated effect-site concentrations and the characteristics of electroencephalogramic changes at unconscious and conscious states

Electroencephalogramic changes during remimazolam general anesthesia: the relationship between estimated effect-site concentrations and the characteristics of electroencephalogramic changes at unconscious and conscious states - Electroencephalogramic changes during remimazolam general anesthesia

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000040606

Enrollment

Registered

2020-06-05

Start date

2020-06-01

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

Of patients who are undergoing elective breast surgery, participants are included if they have both of the following: 1) American Society of Anesthesiologist (ASA) physical status (PS) classification 1 or 2 2) Capability of providing written consent before participation to this study

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Of patients who are undergoing elective breast surgery, participants are included if they have both of the following: 1) American Society of Anesthesiologist (ASA) physical status (PS) classification 1 or 2 2) Capability of providing written consent before participation to this study

Exclusion criteria

Exclusion criteria: Participants are excluded if they have any of the following: 1) Contraindications listed on the package insert of remimazolam (hypersensitivity to any of the components of remimazolam, acute closed angle glaucoma, myasthenia gravis, shock, coma, or acute alcoholic poisoning accompanying suppressed vital signs) 2) Contraindication to benzodiazepine 3) History of long-term administration of benzodiazepine 4) Contraindication to fentanyl, remifentanyl, or rocuronium 5) Severe liver dysfunction, renal dysfunction, or heart disease that may affect the safety assessment of remimazolam 6) ASA PS>=3 7) Others that the investigators consider to be inappropriate for a participant of the study

Design outcomes

Primary

Measure	Time frame
The relationship between estimated effect-site remimazolam concentrations, and frontal EEG changes during general anesthetic induction, maintenance , and emergence phases, respectively.	—

Secondary

Measure	Time frame
The relationship between estimated effect-site remimazolam concentrations, and Patient State Index (PSI) during induction , maintenance , and emergence phases, respectively. The trend in EEG frequency change depending on age. The relationship between age and the time from the end of remimazolam administration to recovery of consciousness.	—

Countries

Japan

Contacts

Public ContactMaiko Hosokawa

Facility of Medicine, Showa University Department of Anesthesiology

maikohskw@med.showa-u.ac.jp03-3784-8575

Outcome results