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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040901
Receipt No. R000045851
Scientific Title Evaluation of the effectiveness of remimazolam for anesthesia in the hepatectomy
Date of disclosure of the study information 2020/06/30
Last modified on 2020/07/04

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Basic information
Public title Evaluation of the effectiveness of remimazolam for anesthesia in the hepatectomy
Acronym Evaluation of the effectiveness of remimazolam for anesthesia in the hepatectomy
Scientific Title Evaluation of the effectiveness of remimazolam for anesthesia in the hepatectomy
Scientific Title:Acronym Evaluation of the effectiveness of remimazolam for anesthesia in the hepatectomy
Region
Japan

Condition
Condition Patients scheduled for hepatectomy under general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The comparison of the clinical effect between remimazolam and propofol during general anesthesia of hepatectomy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time from the end of anesthetic administration to awaking and extubation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 General anesthesia with remimazolam
Interventions/Control_2 Continuous infusion of remimazolam from the induction of general anesthesia to the end of surgery
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients scheduled for hepatectomy under general anesthesia
Key exclusion criteria Patients with disturbance of consciousness
Patients with drug dependence
Patients with uncontrolled hypertension
Patients with acute angle-closure glaucoma
Pregnant women
Lactating women
Patients with myasthenia graves
Patients with severe liver dysfunction
End-stage renal failure or dialysis patients
Patients with alcoholism
Emergency surgery
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Naoyuki
Middle name
Last name Hirata
Organization Sapporo Medical University
Division name Department of Anesthesiology
Zip code 060-8543
Address S1,W16, chu-ou-ku, Sapporo
TEL 011-611-2111
Email naohirata@mac.com

Public contact
Name of contact person
1st name Kenichiro
Middle name
Last name Kikuchi
Organization Sapporo Medical University
Division name Department of Anesthesiology
Zip code 060-8543
Address S1,W16, chu-ou-ku, Sapporo
TEL 011-611-2111
Homepage URL
Email flybabrfr@live.jp

Sponsor
Institute Sapporo Medical University
Institute
Department

Funding Source
Organization none
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 Sapporo Medical University
Address Department of Anesthesiology
Tel 011-211-6111
Email flybabrfr@live.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

Other administrative information
Date of disclosure of the study information
2020 Year 06 Month 30 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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 11 Day
Date of IRB
2020 Year 06 Month 11 Day
Anticipated trial start date
2020 Year 06 Month 30 Day
Last follow-up date
2022 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 06 Month 25 Day
Last modified on
2020 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045851

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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