UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025413 |
|---|---|
| Receipt number | 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 06:14:00 |
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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
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
k.hazama@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki medical school
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021535
