UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013207 |
|---|---|
| Receipt number | R000015410 |
| Scientific Title | Reversibility of Rocuronium-induced Profound Neuromuscular Blockade with Sugammadex in pediatric patient. |
| Date of disclosure of the study information | 2014/02/20 |
| Last modified on | 2014/02/20 16:48:05 |
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Basic information
Public title
Reversibility of Rocuronium-induced Profound Neuromuscular Blockade with Sugammadex in pediatric patient.
Acronym
Reversibility of Rocuronium-induced Profound Neuromuscular Blockade with Sugammadex in pediatric patient.
Scientific Title
Reversibility of Rocuronium-induced Profound Neuromuscular Blockade with Sugammadex in pediatric patient.
Scientific Title:Acronym
Reversibility of Rocuronium-induced Profound Neuromuscular Blockade with Sugammadex in pediatric patient.
Region
| Japan |
Condition
Condition
Surgical pediatric patients requiring general anesthesia.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to clarify an adequate dose and to research characteristics of sugammadex to reverse profound rocuronium-induced neuromuscular blockade in pediatric patients by acceleromyography.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The duration of the recovery to a TOF ratio of 0.9 and 90% of control in T1 after sugammadex was administered.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
At reappearance of 1-2 PTC, a single bolus dose of 1.0mg/kg sugammadex was randomly administered. If there were residual neuromuscular blockade and recurarization, supplementary sugammadex were administered at recovery to a TOF ratio of 0.9.
Interventions/Control_2
At reappearance of 1-2 PTC, a single bolus dose of 2.0mg/kg sugammadex was randomly administered. If there were residual neuromuscular blockade and recurarization, supplementary sugammadex were administered at recovery to a TOF ratio of 0.9.
Interventions/Control_3
At reappearance of 1-2 PTC, a single bolus dose of 4.0mg/kg sugammadex was randomly administered. If there were residual neuromuscular blockade and recurarization, supplementary sugammadex were administered at recovery to a TOF ratio of 0.9.
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
| 1 | months-old | <= |
Age-upper limit
| 24 | months-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients aged 1-23 month
2) Patients of ASA risk classification 1-3
3) Patients that a written informed consent was obtained to participate in this study.
Key exclusion criteria
1)Patients had or suspected neuromuscular disorders.
2)Patients had a hstory of allergy to any medication used during anesthesia.
3) Patients had a history of malignant hyperthermia.
4)Patients had significant hepatic and renal disfunction.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Yamamoto |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Department of Anesthesiology
Zip code
Address
2-8-29 Musashidai Fuchu-shi Tokyo
TEL
042-300-5111
shinichi_yamamoto@tmhp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chihiro Sekijima |
Organization
Saitama Children's Medical Center
Division name
Department of Anesthesiology
Zip code
Address
2100 Magome, Iwatsuki-ku, Saitama 339-8551, Japan
TEL
048-758-1811
Homepage URL
c52yamaguchi@yahoo.co.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Children's Medical Center
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
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
| 2014 | Year | 02 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2011 | Year | 10 | Month | 03 | Day |
Date of closure to data entry
| 2011 | Year | 10 | Month | 03 | Day |
Date trial data considered complete
| 2011 | Year | 10 | Month | 03 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 20 | Day |
Last modified on
| 2014 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015410
