UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025248
Receipt No. R000029042
Scientific Title Compare the muscle relaxation recovery process between TOFwatch and TOFcuff after sugammadex administered
Date of disclosure of the study information 2016/12/13
Last modified on 2018/05/04

* 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 Compare the muscle relaxation recovery process between TOFwatch and TOFcuff after sugammadex administered
Acronym Comparison of TOFwatch and TOFcuff
Scientific Title Compare the muscle relaxation recovery process between TOFwatch and TOFcuff after sugammadex administered
Scientific Title:Acronym Comparison of TOFwatch and TOFcuff
Region
Japan

Condition
Condition Patients who undergo general anesthesia for surgery in which both upper limbs do not become surgical fields
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the utility of TOF cuff by using at the same time during surgery both TOF watch and TOF cuff.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The time until the TOF ratio reached 90% aftersugammadex was administered.
Key secondary outcomes

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
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)Supine position
2)Both upper limbs are not surgical field
3)The patients were ASA physical status 1-2
Key exclusion criteria 1)Patient with neuromuscular disease
2)Patient with liver and renal dysfunction
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hajime Iwasaki
Organization Asahikawa Medical University
Division name Anesthesiology and Critical Care Medicine
Zip code
Address higashi2-1-1-1 Midorigaoka, Asahikawa, Hokkaido, Japan
TEL 0166-65-2111
Email iwasakih@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaya Oshiro
Organization Asahikawa Medical University
Division name Anesthesiology and Critical Care Medicine
Zip code
Address higashi2-1-1-1 Midorigaoka, Asahikawa, Hokkaido, Japan
TEL 0166-65-2111
Homepage URL
Email masaya.o1986@gmail.com

Sponsor
Institute Asahikawa Medical University,Anesthesiology and Critical Care Medicine
Institute
Department

Funding Source
Organization Asahikawa Medical University,Anesthesiology and Critical Care Medicine
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
2016 Year 12 Month 13 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 Open public recruiting
Date of protocol fixation
2016 Year 12 Month 13 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Sugamadex is administered after surgery and the TOF ratio is measured. further, the time from the administration to the time when the TOF ratio reaches 90% is measured.

Management information
Registered date
2016 Year 12 Month 13 Day
Last modified on
2018 Year 05 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029042

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.