UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055225 |
|---|---|
| Receipt number | R000063096 |
| Scientific Title | Investigation of Factors Affecting Recovery Time Following a Single Dose of Rocuronium |
| Date of disclosure of the study information | 2024/08/12 |
| Last modified on | 2025/08/13 13:33:33 |
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Basic information
Public title
Investigation of Factors Affecting Recovery Time Following a Single Dose of Rocuronium
Acronym
Investigation of Factors Affecting Recovery Time Following a Single Dose of Rocuronium
Scientific Title
Investigation of Factors Affecting Recovery Time Following a Single Dose of Rocuronium
Scientific Title:Acronym
Investigation of Factors Affecting Recovery Time Following a Single Dose of Rocuronium
Region
| Japan |
Condition
Condition
Men and women aged 18 and over
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of Factors Affecting the Duration of Action of Muscle Relaxants. The relationship between explanatory factors and the duration of muscle relaxant effects will be compared and examined. Through this verification, the strength of the influence of each factor on the duration of muscle relaxant effects will be identified.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TOF Count 1 Recovery Time of Muscle Relaxants.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients undergoing general anesthesia in whom the administration of muscle relaxants and their antagonists is possible.
Key exclusion criteria
1) Patients with drug allergies to rocuronium, propofol, or sugammadex
2) Patients undergoing surgeries where the administration of muscle relaxants or muscle relaxant antagonists is not desirable
3) Patients using medications that may affect the action of muscle relaxants or their antagonists (e.g., anticonvulsants, female hormone preparations)
4) Other patients deemed unsuitable as study subjects by the principal or sub-investigator
[Rationale for Criteria] 1), 2), 4) Considerations for safety; 3) Considerations for potential impacts on efficacy evaluation.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | TAKAHIRO |
| Middle name | |
| Last name | SUGIURA |
Organization
Kimitsu Central Hospital
Division name
Anesthesiology
Zip code
292-8535
Address
1010 Sakurai, Kisarazu, Chiba
TEL
0438-36-1071
sugiura.takahiro@navy.plala.or.jp
Public contact
Name of contact person
| 1st name | TAKAHIRO |
| Middle name | |
| Last name | SUGIURA |
Organization
Kimitsu central hospital
Division name
Anesthesiology
Zip code
292-8535
Address
1010 Sakurai, Kisarazu, Chiba
TEL
0438361071
Homepage URL
sugiura.takahiro@navy.plala.or.jp
Sponsor or person
Institute
Kimitsu central hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kimitsu central hospital
Address
1010 Sakurai, Kisarazu, Chiba
Tel
0438-36-1071
sugiura.takahiro@navy.plala.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
100
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
Main results already published
Date of protocol fixation
| 2024 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 08 | Month | 12 | Day |
Last modified on
| 2025 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063096
