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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041355
Receipt No. R000047215
Scientific Title Comparison of remimazolam + flumazenil antagonization and propofol on emergence in awake craniotomy: a randomized comparative study
Date of disclosure of the study information 2020/08/11
Last modified on 2021/08/10

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Basic information
Public title Comparison of remimazolam + flumazenil antagonization and propofol on emergence time in patients who undergo awake craniotomy: a randomized comparative study
Acronym Efficacy of remimazolam + flumazenil antagonization and propofol in awake craniotomy
Scientific Title Comparison of remimazolam + flumazenil antagonization and propofol on emergence in awake craniotomy: a randomized comparative study
Scientific Title:Acronym Efficacy of remimazolam + flumazenil antagonization and propofol in awake craniotomy
Region
Japan

Condition
Condition brain tumor
Classification by specialty
Anesthesiology Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Awake craniotomy is applied for temporal lobe brain tumor resection to improve postoperative physical function. Remimazolam, ultra-short acting benzodiazepin, is able to be antagonized by flumazenil, thus it can produce rapid emergence from anesthesia. The purpose of this study is to compare time needed for emergence from general anesthesia between remimazolam + flumazenil antagonization and propofol, conventional sedative.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Time required for emergence from anesthesia
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Remimazolam with flumazenil antagonization is administered in anesthetic management of awake craniotomy
Interventions/Control_2 Propofol is administered in anesthetic management fo awake craniotomy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
65 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key 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)
Key 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
Target sample size 126

Research contact person
Name of lead principal investigator
1st name Shunsuke
Middle name
Last name Tachibana
Organization Sapporo Medical University School of Medicine
Division name Department of Anesthesiology
Zip code 0608543
Address 291, South 1, West 16, Chuo-ku, Sapporo
TEL 011-611-2111
Email chakitomohiro0728@yahoo.co.jp

Public contact
Name of contact person
1st name Tomohiro
Middle name
Last name Chaki
Organization Sapporo Medical University School of Medicine
Division name Department of Anesthesiology
Zip code 0608534
Address 291, South 1, West 16, Chuo-ku, Sapporo
TEL 011-611-2111
Homepage URL
Email chakitomohiro0728@yahoo.co.jp

Sponsor
Institute Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization Sapporo Medical University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB of Sapporo Medical School of University Hospital
Address 291, South 1, West 16, Chuo-ku, Sapporo
Tel 011-611-2111
Email chakitomohiro0728@yahoo.co.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 札幌医科大学附属病院(北海道)

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 11 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2020 Year 07 Month 09 Day
Date of IRB
2020 Year 08 Month 03 Day
Anticipated trial start date
2020 Year 08 Month 11 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 08 Day
Last modified on
2021 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047215

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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