UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040901 |
|---|---|
| Receipt number | 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 | 2023/12/28 09:39:38 |
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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
40
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
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
flybabrfr@live.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
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
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
Open public recruiting
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
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 25 | Day |
Last modified on
| 2023 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045851
