UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032137 |
|---|---|
| Receipt number | R000036606 |
| Scientific Title | The investigation of the withdrawal movement associated with the injection of the generic rocuronium formulation in children |
| Date of disclosure of the study information | 2018/04/09 |
| Last modified on | 2021/10/25 21:57:33 |
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Basic information
Public title
The investigation of the withdrawal movement associated with the injection of the generic rocuronium formulation in children
Acronym
The investigation of the withdrawal movement associated with the injection of the generic rocuronium formulation in children
Scientific Title
The investigation of the withdrawal movement associated with the injection of the generic rocuronium formulation in children
Scientific Title:Acronym
The investigation of the withdrawal movement associated with the injection of the generic rocuronium formulation in children
Region
| Japan |
Condition
Condition
Pediatric patients who are American Society of Anesthesiologists physical status 1 or 2, aged from 2 months to 11 years, and undergoing general anesthesia for scheduled oral surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Eslax has been reported to cause withdrawal movements (injected wrist only, arm only with elbow and shoulder or generalized response or movement) associated with injection pain and its frequency is high in children. Although the generic rocuronium formulation is suggested to have reduced the injection pain in animal study, the clinical utility in children has not been reported yet. In this study, we compare the frequency of withdrawal movements caused by Eslax or generic rocuronium formulation in children.
Basic objectives2
Others
Basic objectives -Others
To verify the degree of side reaction
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of the withdrawal movement associated with the injection of rocuronium
Key secondary outcomes
Degree of the withdrawal movement associated with the injection of rocuronium
Changes in vital signs before and after administration of rocuronium
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pediatric patients who are American Society of Anesthesiologists physical status 1 or 2,aged from 2 months to 11 years, and undergoing general anesthesia for scheduled oral surgery
Key exclusion criteria
1.Patients with history of cardiovascular,respiratory(asthma),liver, kidney,muscle,brain,neurologic disease
2.Obesity
3.Drug allergy
4.Patients who had received analgesics within the previous 24 hours
5.Upper respiratory infection
6.Difficulty securing venous route and difficulty of securing airway
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Mika |
| Middle name | |
| Last name | Inoue |
Organization
Osaka University Graduate School of Dentistry
Division name
Department of Dental Anesthesiology
Zip code
565-0871
Address
1-8,Yamadaoka,Suita,Osaka 565-0871,Japan
TEL
06-6879-2972
mi.sweetbay@gmail.com
Public contact
Name of contact person
| 1st name | Mika |
| Middle name | |
| Last name | noue |
Organization
Osaka University Graduate School of Dentistry
Division name
Department of Dental Anesthesiology
Zip code
565-0871
Address
1-8,Yamadaoka,Suita,Osaka 565-0871,Japan
TEL
06-6879-2972
Homepage URL
mi.sweetbay@gmail.com
Sponsor or person
Institute
Osaka University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Osaka University Graduate School of Dentistry
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
Osaka University Graduate School of Dentistry
Address
1-8,Yamadaoka,Suita,Osaka 565-0871,Japan
Tel
06-6879-2831
si-soumu-syomu@office.osaka-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
大阪大学歯学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 09 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation items
1.Presence or absence of the withdrawal movement associated with the injection of rocuronium
2.Degree of the withdrawal movement associated with the injection of rocuronium
3.Changes in vital signs before and after administration of rocuronium
Management information
Registered date
| 2018 | Year | 04 | Month | 06 | Day |
Last modified on
| 2021 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036606
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