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 UMIN000025413
Receipt No. R000021535
Scientific Title Influence of anesthetics on neuromuscular blocking effect of adductor pollicis and corrugator supercilii muscles
Date of disclosure of the study information 2017/01/01
Last modified on 2018/07/03

* 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 Influence of anesthetics on neuromuscular blocking effect of adductor pollicis and
corrugator supercilii muscles

Acronym Influence of anesthetics on neuromuscular blocking effect of adductor pollicis and
corrugator supercilii muscles
Scientific Title Influence of anesthetics on neuromuscular blocking effect of adductor pollicis and
corrugator supercilii muscles

Scientific Title:Acronym Influence of anesthetics on neuromuscular blocking effect of adductor pollicis and
corrugator supercilii muscles
Region
Japan

Condition
Condition patients undergoing elective surgery
Classification by specialty
Surgery in general Anesthesiology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We compare the neuromuscular effects of rocuronium and rversal effects of sugammadex on adductor pollicis and corrugator supercilii muscles in surgical patients during inhalational or intravenous anesthesia.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the train of four(TOF) ratio of adductor pollicis and corrugator supercilii muscle after administration of ROC and sugammadex during inhalational or intravenous anesthesia
Key secondary outcomes adverse effects of ROC and sugammadex and incidence of postoperative respiratory complications

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients are allocated to one of three groups, desflurane, sevoflurane, propofol.
Anesthetics use for general anesthesia.

desflurane
Interventions/Control_2 sevoflurane
Interventions/Control_3 propofol
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ASA-PS 1-2 patients
over 15 years old
Key exclusion criteria neuromuscular diseases
renal or liver dysfunction
allergy for rocuronium
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Nakatsuka
Organization Kawasaki medical school
Division name Department of anesthesiology and intensive care medicine
Zip code
Address Matsushima577, Kurashiki city, Okayama
TEL 0864621111
Email h.nakatsuka@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Keita Hazama
Organization Kawasaki medical school
Division name Department of anesthesiology and intensive care medicine
Zip code
Address Matsushima577, Kurashiki city, Okayama
TEL 0864621111
Homepage URL
Email k.hazama@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki medical school
Institute
Department

Funding Source
Organization self funding
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
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
2017 Year 01 Month 01 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 Completed
Date of protocol fixation
2016 Year 12 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 26 Day
Last modified on
2018 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021535

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.