UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023404 |
|---|---|
| Receipt number | R000026818 |
| Scientific Title | Study about impact of dilution of rocuronium bromide on onset time of neuromuscular blockade |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2019/07/12 16:31:10 |
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Basic information
Public title
Study about impact of dilution of rocuronium bromide on onset time of neuromuscular blockade
Acronym
Study about impact of dilution of rocuronium bromide on onset time of neuromuscular blockade
Scientific Title
Study about impact of dilution of rocuronium bromide on onset time of neuromuscular blockade
Scientific Title:Acronym
Study about impact of dilution of rocuronium bromide on onset time of neuromuscular blockade
Region
| Japan |
Condition
Condition
patients undergoing general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our hypothesis is that dilution of rocuronium bromide with 0.9% saline (increased volume, same dosage) can change its distribution and consiquently make onset time faster than undiluted solution.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Onset time of neuromuscular blockade
Key secondary outcomes
Duration 25% (time from the start of injection of NMBA until the T1 in the TOF or the single twitch has recovered to 25% of the final value), Duration TOF 0.9 (the time from start of injection of the NMBA until recovery of the TOF ratio to 0.9), rocuronium-induced withdrawal movement
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Group 1 receive undiluted rocuronium 0.6 mg kg-1 over 5 seconds
Interventions/Control_2
Group 2 receive diluted rosuronium 0.6 mg kg-1 in 20 ml 0.9% saline over 5 seconds
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with an ASA physical status 1 or 2, scheduled for elective surgery under general anesthesia using rocuronium and supraglottic device at the Ryukyu university hospital are recruited.
Key exclusion criteria
Patients with severe hepatic, renal, or cardiovascular disease, neuromuscular disease, a history of rocuronium allergy, body mass index >=25 kg/m2 were excluded.
Target sample size
106
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Misuzu Hayashi |
Organization
Ryukyu university hospital
Division name
Department of anesthesiology
Zip code
Address
Uehara 207, Nishihara, Nakagami, Okinawa 903-0125
TEL
098-895-1336
koba_shu1982@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Misuzu Hayashi |
Organization
Ryukyu university hospital
Division name
Department of anesthesiology
Zip code
Address
Uehara 207, Nishihara, Nakagami, Okinawa 903-0125
TEL
098-895-1336
Homepage URL
koba_shu1982@yahoo.co.jp
Sponsor or person
Institute
Ryukyu university
Institute
Department
Personal name
Funding Source
Organization
nothing
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
| 2016 | Year | 08 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 30 | Day |
Last modified on
| 2019 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026818
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| Registered date | File name |
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