UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042519 |
|---|---|
| Receipt number | R000048537 |
| Scientific Title | Remimazolam and Body Weight |
| Date of disclosure of the study information | 2020/11/24 |
| Last modified on | 2020/11/22 23:24:07 |
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Basic information
Public title
Remimazolam and Body Weight
Acronym
R-BW
Scientific Title
Remimazolam and Body Weight
Scientific Title:Acronym
R-BW
Region
| Japan |
Condition
Condition
general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
What is the best body weight to determine infusion rate of remimazolam?
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
intraoperative anesthesia depth measured with SedLine
Key secondary outcomes
intraoperative cardiac parameters
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intraoperative remimazolam infusion rate is determined by real body weight.
Interventions/Control_2
Intraoperative remimazolam infusion rate is determined by ideal body weight based on height.
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
| 15 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
scheduled patients who receive orthopedic disease
Key exclusion criteria
patients getting hemodialysis
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sakamoto |
Organization
Shin Sapporo Orthopaedic Hospital
Division name
Anesthesia
Zip code
0630812
Address
Atsubetsuminami2cyome #2-32, Atsubetsu-ku, Sapporo
TEL
011-893-1161
sakamoto@s-s-orth-hp.or.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | SAKAMOTO |
Organization
Shin Sapporo Orthopaedic Hospital
Division name
Anesthesia
Zip code
004-0022
Address
Atsubetsu2cyome #2-32, Atsubetsu-ku, Sapporo
TEL
011-893-1161
Homepage URL
http://www.s-s-orth-hp.or.jp/index.html
sakamoto@s-s-orth-hp.or.jp
Sponsor or person
Institute
Division of Anesthesia, Shin Sapporo Orthopaedic Hospital
Institute
Department
Personal name
Funding Source
Organization
Division of Anesthesia, Shin Sapporo Orthopaedic Hospital
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
Shin Sapporo Orthopaedic Hospital
Address
Atsubetsu2cyome #2-32, Atsubetsu-ku, Sapporo
Tel
0118931161
sakamoto@s-s-orth-hp.or.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
医療法人新札幌整形外科病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 24 | Day |
Related information
URL releasing protocol
http://www.s-s-orth-hp.or.jp/index.html
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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 03 | 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 | 11 | Month | 22 | Day |
Last modified on
| 2020 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048537
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
