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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034856
Receipt No. R000038938
Scientific Title Assessment of monitored anesthesia care during high-dose-rate brachytherapy for cervical cancer
Date of disclosure of the study information 2019/01/01
Last modified on 2018/11/10

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Basic information
Public title Assessment of monitored anesthesia care during high-dose-rate brachytherapy for cervical cancer
Acronym MAC for RALS
Scientific Title Assessment of monitored anesthesia care during high-dose-rate brachytherapy for cervical cancer
Scientific Title:Acronym MAC for RALS
Region
Japan

Condition
Condition cervical cancer
Classification by specialty
Obsterics and gynecology Radiology Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to investigate effects of monitored anesthesia care during high-dose-rate brachytherapy for cervical cancer on physical and psychological state
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes analgesia, sedation, and side effect
Key secondary outcomes variation of psychological state

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 only during brachytherapy
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria diagnosed with cervical cancer and brachytherapy is planned for treatment
Key exclusion criteria poor general condition for monitored anesthesia care
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takashi Kudo
Organization Hirosaki University Hospital
Division name Anesthesiology
Zip code
Address 53 Hon-cho, Hirosaki City, Aomori
TEL +81-172-39-5113
Email takf5@hirosaki-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takashi Kudo
Organization Hirosaki University Hospital
Division name Anesthesiology
Zip code
Address 53 Hon-cho, Hirosaki City, Aomori
TEL +81-172-39-5113
Homepage URL
Email takf5@hirosaki-u.ac.jp

Sponsor
Institute Hirosaki University Hospital
Institute
Department

Funding Source
Organization Hirosaki University Hospital
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
2019 Year 01 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 Open public recruiting
Date of protocol fixation
2018 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 10 Day
Last modified on
2018 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038938

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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