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Comparison of remimazolam + flumazenil antagonization and propofol on emergence time in patients who undergo awake craniotomy: a randomized comparative study

Comparison of remimazolam + flumazenil antagonization and propofol on emergence in awake craniotomy: a randomized comparative study - Efficacy of remimazolam + flumazenil antagonization and propofol in awake craniotomy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000041355
Enrollment
126
Registered
2020-08-11
Start date
2020-08-11
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

brain tumor

Interventions

Remimazolam with flumazenil antagonization is administered in anesthetic management of awake craniotomy Propofol is administered in anesthetic management fo awake craniotomy

Sponsors

Sapporo Medical University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient aged more than 65 years old age Patient who undergo elective awake craniotomy using asleep-awake-asleep technique Patient whose preoperative physical status is good (ASA-PS 1-3)

Exclusion criteria

Exclusion criteria: Patient who has allergy for propofol, remimazolam and flumazenil Patient who has severe hepatic and/or renal dynfunction Patient who determined as inappropriate for enrollment by the researcher of this study

Design outcomes

Primary

MeasureTime frame
Time required for emergence from anesthesia

Secondary

MeasureTime frame
Time required for extubation Time course of sedative score Serum concentration of remimazolam and propofol Blood pressure, heart rate and SpO2 during general anesthesia Incidence of awake craniotomy failure Dose of flumazenil Incidence of unintended re-sedation during awake phase Dose required for re-anesthesia induction Time required for re-anesthesia induction Time required for re-emergence Incidence of nausea and vomiting during awake phase

Countries

Japan

Contacts

Public ContactTomohiro Chaki

Sapporo Medical University School of Medicine Department of Anesthesiology

chakitomohiro0728@yahoo.co.jp011-611-2111

Outcome results

None listed

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