UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041355 |
|---|---|
| Receipt number | 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 15:00:07 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
chakitomohiro0728@yahoo.co.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047215
