UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006219 |
|---|---|
| Receipt number | R000007363 |
| Scientific Title | Influence of infusion method of rocuronium on pharmacokinetics and pharmacodynamics of rocuronium |
| Date of disclosure of the study information | 2011/08/23 |
| Last modified on | 2024/03/02 09:26:58 |
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Basic information
Public title
Influence of infusion method of rocuronium on pharmacokinetics and pharmacodynamics of rocuronium
Acronym
Influence of infusion method of rocuronium on pharmacokinetics and pharmacodynamics of rocuronium
Scientific Title
Influence of infusion method of rocuronium on pharmacokinetics and pharmacodynamics of rocuronium
Scientific Title:Acronym
Influence of infusion method of rocuronium on pharmacokinetics and pharmacodynamics of rocuronium
Region
| Japan |
Condition
Condition
patient undergoing elective surgery under general anesthesia
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to examine the effect of infusion method of neuromuscular blockade on pharmacokinetics and pharmacodynamics of neuromuscular blockade.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pharmacodynamic effect of neuromuscular blockade
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
rocuronium 0.6 mg/kg is administered at 1 mg/kg/min followed by rocuronium administration between 5 to 15 mcg/kg/min
Interventions/Control_2
rocuronium 0.6 mg/kg is administered at 0.75 mg/kg/min followed by rocuronium administration between 5 to 15 mcg/kg/min
Interventions/Control_3
rocuronium 0.6 mg/kg is administered at 0.5 mg/kg/min followed by rocuronium administration between 5 to 15 mcg/kg/min
Interventions/Control_4
rocuronium 0.6 mg/kg is administered at 0.25 mg/kg/min followed by rocuronium administration between 5 to 15 mcg/kg/min
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients undergoing elective surgery under general anesthesia
Key exclusion criteria
significant heart, respiratory, hepatic, or renal impairment; neuromuscular disease; body mass index greater than 30
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Masui |
Organization
National Defense Medical College Hospital
Division name
Department of Anesthesiology
Zip code
359-8513
Address
Namiki 3-2, Tokorozawa, Saitama, Japan
TEL
04-2995-1511
kenichi@masuinet.com
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Masui |
Organization
National Defense Medical College
Division name
Department of Anesthesiology
Zip code
359-8513
Address
Namiki 3-2, Tokorozawa, Saitama
TEL
04-2995-1511
Homepage URL
kenichi@masuinet.com
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
National Defense Medical College and
Departmental Funding
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Defense Medical College
Address
Namiki 3-2, Tokorozawa, Saitama, Japan
Tel
04-2995-1211
honrinri@ndmc.ac.jp
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
| 2011 | Year | 08 | Month | 23 | 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
76
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Under analysis
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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 23 | Day |
Last modified on
| 2024 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007363
