UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024742 |
|---|---|
| Receipt number | R000028466 |
| Scientific Title | Effects of reversal of neuromuscular blockades on QT dispersion under profpofol anesthesia |
| Date of disclosure of the study information | 2016/11/10 |
| Last modified on | 2018/10/16 14:59:47 |
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Basic information
Public title
Effects of reversal of neuromuscular blockades on QT dispersion under profpofol anesthesia
Acronym
Effects of reversal of neuromuscular blockades on QT dispersion
Scientific Title
Effects of reversal of neuromuscular blockades on QT dispersion under profpofol anesthesia
Scientific Title:Acronym
Effects of reversal of neuromuscular blockades on QT dispersion
Region
| Japan |
Condition
Condition
Patients who scheduled to undergo elective otorhinolaryngological surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of neostigmine and sugammadex on QT and QT dispersion
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After the operation, sugammadex or neostigmine are given, then QT and QT dispersion are measured.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
After the operation,sugammadexare given, then QT and QTD are measured by 12-lead ECG.
Interventions/Control_2
After the operation,neostignmine are given, then QT and QTD are measured by 12-lead ECG.
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
ASA physical status I or II patients who are scheduled to undergo elective otorhinolaryngological surgery are studied.
Key exclusion criteria
All patients with cardiovascular respiratory, metabolic or cerebrovascular disease were excluded. Patients with predicted difficulty in tracheal intubation were also excluded.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeki Yamaguchi |
Organization
Dokkyo Medical University
Division name
Anesthesiology
Zip code
Address
880 Kitakobayashi, Mibu, Tochigi
TEL
0282-86-1111
takasusu@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshifumi Takasusuki |
Organization
Dokkyo Medical University
Division name
Anesthesiology
Zip code
Address
880 Kitakobayashi, Mibu, Tochigi
TEL
0282-86-1111
Homepage URL
takasusu@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
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 | 11 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Neostigmine significantly prolonged the QTcD dispersion/baseline compared to sugammadex.
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
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 07 | Day |
Last modified on
| 2018 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028466
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
