UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030677 |
|---|---|
| Receipt number | R000035023 |
| Scientific Title | Comparison of injection pain between original and generic rocuronium |
| Date of disclosure of the study information | 2018/01/05 |
| Last modified on | 2021/04/09 16:04:20 |
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Basic information
Public title
Comparison of injection pain between original and generic rocuronium
Acronym
Comparison of original and generic rocuronium
on injection pain
Scientific Title
Comparison of injection pain between original and generic rocuronium
Scientific Title:Acronym
Comparison of original and generic rocuronium
on injection pain
Region
| Japan |
Condition
Condition
Patients undergoing operations under general anesthesia, not limited to specific diseases
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The incidence of rocuronium injection pain has been reported. It has been suggested that generic rocuronium, which has glycine as one of the buffer materials, can reduce injection pain on study in rats. Our objective is to compare injection pain caused by between original and generic rocuronium in patients undergoing operations under general anesthesia.
Basic objectives2
Others
Basic objectives -Others
To verify the efficacy and the degree of side reactions
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Movement of the extremities after injecting rocuronium
Perfusion index
Changes of vital signs
Key secondary outcomes
Efficacy and the degree of side reactions of rocuronium
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved 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
We inject generic rocuronium 0.9 mg/kg into a vein after induction of general anesthesia with propofol or thiamylal.
Interventions/Control_2
We inject original rocuronium 0.9 mg/kg into a vein after induction of general anesthesia with propofol or thiamylal.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who undergo operations under general anesthesia
Key exclusion criteria
Patient with allergy of rocuronium, propofol and thiamyral
Patients with neuromuscular disease
Obesity patients (BMI 35 or higher)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunobu Takahashi |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
S1 W17, Chuo-ku, Sapporo,Hokkaido, 060-8556, Japan
TEL
+81-11-611-2111
takahashi.k@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunobu Takahashi |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
S1 W17, Chuo-ku, Sapporo,Hokkaido, 060-8556, Japan
TEL
+81-11-611-2111
Homepage URL
takahashi.k@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
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
Address
Tel
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
| 2018 | Year | 01 | Month | 05 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00540-020-02889-2
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00540-020-02889-2
Number of participants that the trial has enrolled
40
Results
Generic rocuronium was considered more suitable than the original rocuronium for induction of anesthesia by propofol performed with a target-controlled infusion system.
Results date posted
| 2021 | Year | 04 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
class I or II patients as per American Society of Anesthesiologists
Participant flow
Based on computer-generated randomization charts, patients were randomly divided into two groups, generic rocuronium group (Group G) and original rocuronium group (Group O).
Adverse events
none
Outcome measures
The primary outcome was the total incidence of movement after administration of rocuronium.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 04 | Day |
Last modified on
| 2021 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035023
