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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002556
Receipt No. R000003124
Scientific Title Monitoring of neuromuscular block caused by rocuronium at the orbicularis oris, corrugator supercilli, or adductor pollicis muscle
Date of disclosure of the study information 2009/09/29
Last modified on 2011/03/21

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Basic information
Public title Monitoring of neuromuscular block caused by rocuronium at the orbicularis oris, corrugator supercilli, or adductor pollicis muscle
Acronym Neuromuscular monitoring at the orbicularis oris, corrugator supercilli, or adductor pollicis muscle
Scientific Title Monitoring of neuromuscular block caused by rocuronium at the orbicularis oris, corrugator supercilli, or adductor pollicis muscle
Scientific Title:Acronym Neuromuscular monitoring at the orbicularis oris, corrugator supercilli, or adductor pollicis muscle
Region
Japan

Condition
Condition Abdominal diseases which need surgical procedure under general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 It has become popular to monitor the degree of neuromuscular block at the corrugator supercilli muscle. However, nowadays a probe for the entropy or bispectral index which assesses the depth of amnesia is commonly placed near the corrugator supercilli muscle. Therefore, it is difficult to evaluate the level of neuromuscular block near the corrugator supercilli muscle. The aim of this study is to monitor the degree of neuromuscular block at the orbicularis oris muscle.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The onset time of neuromuscular block, the degree of the maximum neuromuscular block, and recovery of neuromuscular block during 2 hours are evaluated and compared after rocuronium 0.6 mg/kg iv at the orbicularis oris, corrugator supercilli, and adductor pollicis muscles.
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 (1)Onset of neuromsucular block after rocuronium 0.6mg/kg iv, (2)maximum effect of neuromuscular block after rocuronium 0.6mg/kg iv assessed using train-of-four stimulation, and (3)recovery of neuromuscular block after rocuronium 0.6mg/kg iv assessed using train-of-four stimulation at the orbicularis oris muscle are compared with those at the adductor pollicis muscle.
Interventions/Control_2 (1)Onset of neuromsucular block after rocuronium 0.6mg/kg iv, (2)maximum effect of neuromuscular block after rocuronium 0.6mg/kg iv assessed using train-of-four stimulation, and (3)recovery of neuromuscular block after rocuronium 0.6mg/kg iv assessed using train-of-four stimulation at the corrugator supercilli muscle are compared with those at the adductor pollicis muscle.
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Healthy patients scheduled for abdominal surgery under general anesthesia will be studied. Patients of both sexes, aged from 20 to 85 will be included.
Key exclusion criteria Unhealthy patients with American Society of Anesthesiologists (ASA)physical status of more than 3.
Patients with neuromuscular, hepatic, renal, cardiac, metabolic disease.
Patients taking drugs to affect with the action of neuromuscular relaxant.
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuhji Saitoh
Organization Tsujinaka Hospital Kashiwanoha
Division name Department of Anesthesiology
Zip code
Address 146-6, Kashiwanoha Campus, 178-2, Wakashiba, Kashiwa-City, Chiba, 277-0871, Japan
TEL 04-7137-3737
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yuhji Saitoh
Organization Tsujinaka Hospital Kashiwanoha
Division name Department of Anesthesiology
Zip code
Address 146-6, Kashiwanoha Campus, 178-2, Wakashiba, Kashiwa-City, Chiba, 277-0871, Japan
TEL 04-7137-3737
Homepage URL
Email ysz432@yahoo.co.jp

Sponsor
Institute Tsujinaka Hospital Kashiwanoha
Institute
Department

Funding Source
Organization Tsujinaka Hospital Kashiwanoha
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
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 辻仲病院柏の葉

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 29 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
2009 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2009 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 09 Month 28 Day
Last modified on
2011 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003124

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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