UMIN-CTR Clinical Trial

Basic information
Public title	The influence of aging on the time lag of the detection of twitch response between subjective and objective neuromuscular monitoring.
Acronym	Aging and the time lag between subjective and objective neuromuscular monitoring.
Scientific Title	The influence of aging on the time lag of the detection of twitch response between subjective and objective neuromuscular monitoring.
Scientific Title:Acronym	Aging and the time lag between subjective and objective neuromuscular monitoring.
Region	Japan

Condition
Condition	Patients undergoing general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To test a hypothesis that aging effects the time lag between the detection (or the disappearance) of twitch response evaluated subjectively and that evaluated objectively.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The time lag of the onset and duration of rocuronium between subjective and objective neuromuscular monitoring.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Adult patients scheduled for surgeries under general anesthesia
Key exclusion criteria	1)Patients having allergic factors to rocuronium or sugammadex 2)BMI 30 kg/m2 and above or below 18.5 kg/m2 3)cirrhosis, hepatitis 4)heart failure 5)renal dysfunction 6)neuromuscular disorder
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Masafumi Middle name Last name Fujimoto
Organization	Nishinihon Hospital
Division name	Department of anesthesiology
Zip code	861-8034
Address	3-20-1, Hattannda, Higashiku, Kumamoto-City, Kumamoto
TEL	0963801111
Email	mfujimoto.kmm@gmail.com

Public contact
Name of contact person	1st name Masafumi Middle name Last name Fujimoto
Organization	Nishinihon Hospital
Division name	Department of anesthesiology
Zip code	861-8034
Address	3-20-1, Hattannda, Higashiku, Kumamoto-City, Kumamoto
TEL	0963801111
Homepage URL
Email	mfujimoto.kmm@gmail.com

Sponsor
Institute	Nishinihon Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nishinihon Hospital IRB
Address	3-20-1, Hattannda, Higashiku, Kumamoto-City, Kumamoto
Tel	0963801111
Email	jimubu@nishinihon.or.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	2021 Year 10 Month 16 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	2021 Year 09 Month 15 Day
Date of IRB	2021 Year 09 Month 16 Day
Anticipated trial start date	2021 Year 10 Month 16 Day
Last follow-up date	2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	onset time, duration time, Intubation condition.

Management information
Registered date	2021 Year 10 Month 15 Day
Last modified on	2021 Year 10 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051942