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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027916
Receipt No. R000031341
Scientific Title Reversal of neuromuscular block by sugammadex for peripheral nerve block using combined ultrasound and neurostimulation guidance under general anesthesia
Date of disclosure of the study information 2017/06/30
Last modified on 2017/06/25

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Basic information
Public title Reversal of neuromuscular block by sugammadex for peripheral nerve block using combined ultrasound and neurostimulation guidance under general anesthesia
Acronym Reversal of neuromuscular block for peripheral nerve block under general anesthesia
Scientific Title Reversal of neuromuscular block by sugammadex for peripheral nerve block using combined ultrasound and neurostimulation guidance under general anesthesia
Scientific Title:Acronym Reversal of neuromuscular block for peripheral nerve block under general anesthesia
Region
Japan

Condition
Condition Patients who undergo upper or lower extremity surgery under general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to evaluate whether reversal of neuromuscular block by sugammadex enable us to use combined ultrasound and neurostimulation guidance for peripheral nerve block.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy of dual guidance (nerve stimulation) for peripheral nerve block under general anesthesia
Key secondary outcomes dose of sugammadex in reversing neuromuscular block,
the degree of neuromuscular blockade assessed using TOF Watch SX, threshold current in nerve stimulation,
adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 administration of sugammadex (2 mg kg-1) before peripheral nerve block
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 Patients aged 20 yr or older, with ASA physical status I-III, scheduled to receive general anesthesia and nerve blocks for the upper or lower extremity surgery
Key exclusion criteria patients with neuromuscular disease, severe diabetes mellitus, or allergy to local anesthetics, muscle relaxants or sugammadex
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuyoshi Aoyama
Organization Kitakyushu General Hospital
Division name Department of Anesthesia
Zip code
Address 1-1 Higashijono-machi, Kokurakita-ku, Kitakyushu
TEL 093-921-0560
Email kazuyoshi.aoyama@kitakyu-hp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuyoshi Aoyama
Organization Kitakyushu General Hospital
Division name Department of Anesthesia
Zip code
Address 1-1 Higashijono-machi, Kokurakita-ku, Kitakyushu
TEL 093-921-0560
Homepage URL
Email kazuyoshi.aoyama@kitakyu-hp.or.jp

Sponsor
Institute Kitakyushu General 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
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 北九州総合病院(福岡県)

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 30 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 Open public recruiting
Date of protocol fixation
2017 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 30 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
2017 Year 06 Month 25 Day
Last modified on
2017 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031341

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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