UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034996
Receipt No. R000039747
Scientific Title Comparison of Responses of Electromyogram and Acceleromyogram Neuromuscular Monitoring in Deep Muscle Relaxation by rocuronium, open-label, multicenter study
Date of disclosure of the study information 2018/11/26
Last modified on 2019/05/27

* 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 Comparison of Responses of Electromyogram and Acceleromyogram Neuromuscular Monitoring in Deep Muscle Relaxation by rocuronium, open-label, multicenter study
Acronym Comparison of Responses of EMG and AMG Neuromuscular Monitoring in Deep Muscle Relaxation
Scientific Title Comparison of Responses of Electromyogram and Acceleromyogram Neuromuscular Monitoring in Deep Muscle Relaxation by rocuronium, open-label, multicenter study
Scientific Title:Acronym Comparison of Responses of EMG and AMG Neuromuscular Monitoring in Deep Muscle Relaxation
Region
Japan

Condition
Condition Patients undergoing surgery under general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We aim to compare clinical standard compatibility when muscle relaxants and antagonists are used by comparing measured values of AF-201P (Nihon Kohden Corporation) and TOF Watch(Nihon Kohden Corporation).
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Time from rocuronium administration to first appearance of post-tetanic counts (min)
Key secondary outcomes Time course of post-tetanic counts values

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
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria Patients undergoing surgery under general anesthesia using rocuronium as neuromuscular blocking agent.
ASA physical status1-3.
Key exclusion criteria Patients who have a history of allergies to muscle relaxants or antagonists
Case of severe systemic complications
Obesity patients with BMI 30 or more and low body weight patients below 18.5
Patients with neuromuscular disease
Case with significant liver dysfunction
Patient who has cardiac pacemaker, implantable cardioverter defibrillator (ICD) in place
Pregnant women, patients who may be pregnant
Others who judged that the research director is inappropriate as the research subject
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Shunichi
Middle name
Last name Takagi
Organization Itabashi Hospital, Nihon University School of Medicine
Division name Department of Anesthesiology
Zip code 1738610
Address 30-1 Oyaguchikamicho, Itabashi-ku, Tokyo
TEL 03-3972-8111
Email takagi.shunichi@nihon-u.ac.jp

Public contact
Name of contact person
1st name Shunichi
Middle name
Last name takagi
Organization Itabashi Hospital, Nihon University School of Medicine
Division name Department of Anesthesiology
Zip code 1738610
Address 30-1 Oyaguchikamicho, Itabashi-ku, Tokyo
TEL 03-3972-8111
Homepage URL
Email takagi.shunichi@nihon-u.ac.jp

Sponsor
Institute Department of Anesthesiology, Itabashi Hospital, Nihon University School of Medicine
Institute
Department

Funding Source
Organization NIHON KOHDEN CORPORATION
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Anesthesiology, Asahikawa Medical University Hospital
Department of Anesthesiology, Toho University Ohashi Medical Center
Department of Anesthesiology, Kagoshima Medical Association Hospital
Department of Anesthesiology, Kawasaki Medical School Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Itabashi Hospital, Nihon University School of Medicine
Address 30-1 Oyaguchikamicho, Itabashi-ku, Tokyo
Tel 0339728111
Email shunichi.takagi@nihon-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 旭川医科大学病院(北海道)、東邦大学大橋病院(東京都)、鹿児島市医師会病院(鹿児島県)、川崎医科大学付属病院(岡山県)

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 26 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 Enrolling by invitation
Date of protocol fixation
2019 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date
2019 Year 11 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We aim to compare clinical standard compatibility when muscle relaxants and antagonists are used by comparing measured values of AF-201P (Nihon Kohden Corporation) and TOF Watch (Nihon Kohden Corporation).

Management information
Registered date
2018 Year 11 Month 26 Day
Last modified on
2019 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039747

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.