UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010240 |
|---|---|
| Receipt number | R000011987 |
| Scientific Title | Rocuronium-induced neuromuscular block and reversibility with sugammadex at the corrugator supercilii and adductor pollicis muscles |
| Date of disclosure of the study information | 2013/03/14 |
| Last modified on | 2015/11/26 22:37:50 |
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Basic information
Public title
Rocuronium-induced neuromuscular block and reversibility with sugammadex at the corrugator supercilii and adductor pollicis muscles
Acronym
Rocuronium and sugammadex at the corrugator supercilli
Scientific Title
Rocuronium-induced neuromuscular block and reversibility with sugammadex at the corrugator supercilii and adductor pollicis muscles
Scientific Title:Acronym
Rocuronium and sugammadex at the corrugator supercilli
Region
| Japan |
Condition
Condition
Surgical patients requiring general anesthesia
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will accelermyographically monitor rocuronium-induced neuromuscular blockade and the reversibility with sugammadex at the corrugator superciliiand adductor pollicis muscles.In this study, adequate doses of sugammadex for the reversal of neuromusclar block induced at the both muscles should be adjusted.In addition, we wll aim to elucidate which muscle should be monitored to evaluate adequte recovery of neuromusclar function.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Optimum dose of sugammadex for the reversal of neuromuscular blockade at the corrugator supercilii muscle.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The patients will recive sugammadex 2mg/kg when the height of the twich in a train of four(TOF) stimlation willbe maintained at 10% of the control, and the time requred for the facilitated recovery to a TOF ratio of 0.9 will be recorded.
Interventions/Control_2
The patients will recive sugammadex 4mg/kg when the height of the twich in a train of four(TOF) stimlation willbe maintained at 10% of the control, and the time requred for the facilitated recovery to a TOF ratio of 0.9 will be recorded.
Interventions/Control_3
The patients will recive sugammadex 4mg/kg when the height of the twich in a train of four(TOF) stimlation willbe maintained at 10% of the control, and recorded the difference in the speed of recovery from rocuronium-induced neuromuscular block in the corrugator supercilii and adductor pollicis muscles.
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
1)Patients aged 20 years old and above
2) ASA risk classification 1 and 2
3) Patients consented to participate in this study
Key exclusion criteria
1)Patients having allergic factors to neuromuscular blocking agents
2) ASA risk 4 and above
3) BMI 30 and above or below 18.5
4)Patients having hepatic and renal disorders
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Suzuki |
Organization
Nihon University of Medicine
Division name
Department of Anesthesiology
Zip code
Address
30-1 Oyaguchi-Kamimachi Itabashi-Ku Tokyo
TEL
03-3972-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nihon University of Medicine
Division name
Department of Anesthesiology
Zip code
Address
TEL
03-3972-8111
Homepage URL
Sponsor or person
Institute
Nihon University of Medicine Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Nihon University of Medicine Department of Anesthesiology
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 14 | 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
| 2012 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | 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
| 2013 | Year | 03 | Month | 14 | Day |
Last modified on
| 2015 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011987
