UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032137
Receipt No. 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 2018/04/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Mika Inoue
Organization Osaka University Graduate School of Dentistry
Division name Department of Dental Anesthesiology
Zip code
Address 1-8,Yamadaoka,Suita,Osaka 565-0871,Japan
TEL 06-6879-2972
Email mika-ino@dent.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mika Inoue
Organization Osaka University Graduate School of Dentistry
Division name Department of Dental Anesthesiology
Zip code
Address 1-8,Yamadaoka,Suita,Osaka 565-0871,Japan
TEL 06-6879-2972
Homepage URL
Email mika-ino@dent.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Dentistry
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2017 Year 12 Month 18 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 09 Day
Last follow-up date
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
2018 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036606

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.