UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008740 |
|---|---|
| Receipt number | R000010264 |
| Scientific Title | Relationship between onset of rocuronium-induced neuromuscular block and cardiac output in elderly patients |
| Date of disclosure of the study information | 2012/08/21 |
| Last modified on | 2018/02/27 17:22:14 |
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Basic information
Public title
Relationship between onset of rocuronium-induced neuromuscular block and cardiac output in elderly patients
Acronym
Rocuronium and CO
Scientific Title
Relationship between onset of rocuronium-induced neuromuscular block and cardiac output in elderly patients
Scientific Title:Acronym
Rocuronium and CO
Region
| Japan |
Condition
Condition
Surgical patients requiring general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In elderly patients, onset of rocuronium-induced neuromuscular block markedly varies among individual patients and tends to delay when compared with younger adults. It is anticipated that the delayed onset of the action of rocuronium may relate to the difference in cardiac output. We will examine a correlation between the onset time of rocuronium and cardiac output and hope to contribute to safe tracheal intubation in elderly patients.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
onset time of rocuronium-induced neuromuscular block at the adductor pollicis muscle and arterial pressure based cardiac output
Key secondary outcomes
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
A correlation between onset of the action of rocuronium 1mg/kg and arterial pressure cardiac output will be analyzed.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients aged 65 years old and above
2) ASA risk classification 1, 2 and 3
3) Patients requiring invasive arterial pressure and arterial pressure based cardiac output
4) Patients consented to participate in this study
Key exclusion criteria
1) Not satisfy selection criteria noted above
2) Patients having allergic factors to neuromuscular blocking agents
3) ASA risk 4 and above
4) BMI 30 and above or below 18.5
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Suzuki |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
30-1 Oyaguchi-Kamimachi Itabashi-Ku Tokyo
TEL
03-3972-8111
suzuki.takahiro@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Suzuki |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
30-1 Oyaguchi-Kamicho, Itabshi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
suzuki.takahiro@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Departmental funding
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
日本大学医学部附属板橋病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 21 | 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 | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 21 | Day |
Last modified on
| 2018 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010264
