UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054501 |
|---|---|
| Receipt number | R000061041 |
| Scientific Title | Effect of bolus administration of remimazolam during induction of general anaesthesia on hemodynamic variables in patients undergoing hip replacement and endoscopic sinus surgery. |
| Date of disclosure of the study information | 2024/05/30 |
| Last modified on | 2024/05/29 08:59:02 |
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Basic information
Public title
Effect of bolus administration of remimazolam during induction of general anaesthesia on hemodynamic variables in patients undergoing hip replacement and endoscopic sinus surgery.
Acronym
Bolus administration of remimazolam and hemodynamic variables.
Scientific Title
Effect of bolus administration of remimazolam during induction of general anaesthesia on hemodynamic variables in patients undergoing hip replacement and endoscopic sinus surgery.
Scientific Title:Acronym
Bolus administration of remimazolam and hemodynamic variables.
Region
| Japan |
Condition
Condition
Osteoarthritis and sinusitis
Classification by specialty
| Oto-rhino-laryngology | Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of remimazolam in bolus dosing on circulatory
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum change in mean blood pressure immediately before remimazolam administration and every minute up to 5 minutes after administration
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years and less than 80 years between 1 September 2023 and 31 March 2025 with an American Society of Anaesthesiologists general status classification (ASA-PS)1 or 2 for planned hip replacement and endoscopic sinus surgery.
Key exclusion criteria
Emergency surgery, history of cardiovascular disease, pregnancy, history of severe liver dysfunction, on dialysis, history of neurological disease, history of drug hypersensitivity, history of severe lipid metabolism disorders, BMI >30 kg/m2.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | TOMOHARU |
| Middle name | |
| Last name | SHAKUO |
Organization
Showa University Northern Yokohama Hospital
Division name
Department of Anesthesiology
Zip code
2248503
Address
35-1, Chigasaki-chuo, Tsuzuki-ku, Yokohama City, Kanagawa-Ken
TEL
0459497000
tomoharu.shakuo@gmail.com
Public contact
Name of contact person
| 1st name | TOMOHARU |
| Middle name | |
| Last name | SHAKUO |
Organization
Showa University Northern Yokohama Hospital
Division name
Department of Anesthesiology
Zip code
2248503
Address
35-1, Chigasaki-chuo, Tsuzuki-ku, Yokohama City, Kanagawa-Ken
TEL
0459497000
Homepage URL
shakuo@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Research Ethics Review Board
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-8000
m-rinri@ofc.showa-u.ac.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
| 2024 | Year | 05 | 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
30
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
| 2023 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing Particular
Management information
Registered date
| 2024 | Year | 05 | Month | 29 | Day |
Last modified on
| 2024 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061041
