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 UMIN000042488
Receipt No. R000048208
Scientific Title neuromuscular blockade induced by rocuronium in the elderly A study of the utility of masseter muscle nerve stimulation and monitoring of masseter muscle contraction response
Date of disclosure of the study information 2020/11/20
Last modified on 2020/11/18

* 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 neuromuscular blockade induced by rocuronium in the elderly
A study of the utility of masseter muscle nerve stimulation and monitoring of masseter muscle contraction response
Acronym neuromuscular blockade induced by rocuronium in the elderly
A study of the utility of masseter muscle nerve stimulation and monitoring of masseter muscle contraction response
Scientific Title neuromuscular blockade induced by rocuronium in the elderly
A study of the utility of masseter muscle nerve stimulation and monitoring of masseter muscle contraction response
Scientific Title:Acronym neuromuscular blockade induced by rocuronium in the elderly
A study of the utility of masseter muscle nerve stimulation and monitoring of masseter muscle contraction response
Region
Japan

Condition
Condition Patients scheduled for elective surgery requiring general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The rocuronium muscle relaxation response in the elderly
A study of the utility of masseter muscle nerve stimulation and monitoring of masseter muscle contraction response
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between masseter muscle thickness and effective dose of rocuronium
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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria the patients scheduled for elective surgery requiring general anesthesia

the patients were ASA physical status 1-3
Key exclusion criteria the patients were ASA physical status 4-6

Patients with a history of allergy to muscle relaxants or antagonists
Severe systemic complications (American Society of Anesthesiologists preanesthesia risk rating of 4 or higher)
Obese patients with a BMI of 30 or more, and patients with a BMI of less than 18.5
Patients with neuromuscular diseases
Cases with liver dysfunction
Any other person who is judged by the principal investigator to be unsuitable as a research subject
Target sample size 50

Research contact person
Name of lead principal investigator
1st name OSAMU
Middle name
Last name KITAJIMA
Organization Nihon University School of Medicine
Division name Department of Anesthesiology
Zip code 1738610
Address 30-1,Oyaguchi,kamimati,Itabasi-ku,Tokyo
TEL 81339728111
Email kitajima.osamu@nihon-u.ac.jp

Public contact
Name of contact person
1st name OSAMU
Middle name
Last name KITAJIMA
Organization Nihon University School of Medicine
Division name Department of Anesthesiology
Zip code 1738610
Address 30-1,Oyaguchi,kamimati,Itabasi-ku,Tokyo
TEL 81339728111
Homepage URL
Email kitajima.osamu@nihon-u.ac.jp

Sponsor
Institute Department of Anesthesiology
Nihon University School of Medicine
Institute
Department

Funding Source
Organization Department of Anesthesiology
Nihon University School of 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 Nihon University School of Medicine
Address 30-1,Oyaguchi,kamimati,Itabasi-ku,Tokyo
Tel 81339728111
Email kitajima.osamu@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

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 20 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
2020 Year 10 Month 17 Day
Date of IRB
2020 Year 11 Month 20 Day
Anticipated trial start date
2020 Year 11 Month 24 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information elderly person
rocuronium
masseter muscle
neuromuscular monitoring

Management information
Registered date
2020 Year 11 Month 18 Day
Last modified on
2020 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048208

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.