UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013207
Receipt No. 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

* 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 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
Email 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
Email c52yamaguchi@yahoo.co.jp

Sponsor
Institute Tokyo Metropolitan Children's Medical Center
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015410

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.