UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002556 |
|---|---|
| Receipt number | 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 19:55:58 |
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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
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
ysz432@yahoo.co.jp
Sponsor or person
Institute
Tsujinaka Hospital Kashiwanoha
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003124
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