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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024742
Receipt No. 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

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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
Email 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
Email takasusu@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028466

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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