UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000047215