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Usefulness of the Aperiodic Component for Assessing Sedation Depth During Remimazolam Administration: A Prospective Observational Study

Usefulness of the Aperiodic Component for Assessing Sedation Depth During Remimazolam Administration: A Prospective Observational Study - Usefulness of the Aperiodic Component for Assessing Sedation Depth During Remimazolam Administration: A Prospective Observational Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000059787
Enrollment
23
Registered
2025-11-15
Start date
2025-11-15
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

Patients undergoing general anesthesia in the operation room

Interventions

Administration of remimazolam

Sponsors

Fukushima Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Patients managed by the attending anesthesiologist 2. Female sex 3. Age between 40 and 65 years 4. ASA physical status I or II

Exclusion criteria

Exclusion criteria: 1. Inability to obtain informed consent 2. Presence of central nervous system disorders (cognitive impairment, stroke, epilepsy, brain tumor, or psychiatric disorders) 3. Use of antiepileptic drugs 4. Allergy to benzodiazepines 5. Current use of benzodiazepines 6. Risk of difficult airway, defined as: Obesity with a BMI greater than 30 Upper lip bite test class 3 Difficult airway anticipated by the attending anesthesiologist 7. Any other condition judged inappropriate for the study by the attending anesthesiologist or the principal investigator

Design outcomes

Primary

MeasureTime frame
The area under the receiver operating characteristic (ROC) curve (AUC) for the aperiodic component to discriminate between the awake and anesthetized states

Countries

Japan

Contacts

Public ContactTakayuki Hasegawa

Fukushima Medical University Department of Anesthesiology

masui@fmu.ac.jp0245471111

Outcome results

None listed

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