UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034856
Receipt number 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 2023/04/07 09:59:21

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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

Obstetrics 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

Name of lead principal investigator

1st name Takashi
Middle name
Last name Kudo

Organization

Hirosaki University Hospital

Division name

Anesthesiology

Zip code

0368563

Address

53 Hon-cho, Hirosaki City, Aomori

TEL

+81-172-39-5113

Email

takf5@hirosaki-u.ac.jp


Public contact

Name of contact person

1st name Takashi
Middle name
Last name Kudo

Organization

Hirosaki University Hospital

Division name

Anesthesiology

Zip code

0368563

Address

53 Hon-cho, Hirosaki City, Aomori

TEL

+81-172-39-5113

Homepage URL


Email

takf5@hirosaki-u.ac.jp


Sponsor or person

Institute

Hirosaki University Hospital

Institute

Department

Personal name



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

Hirosaki University Graduate School of MedicineInstitutional Review Board

Address

5,Zaifucho,Hirosaki,Aomori

Tel

0172395203

Email

rinri@hirosaki-u.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

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

Completed

Date of protocol fixation

2018 Year 08 Month 01 Day

Date of IRB

2018 Year 09 Month 21 Day

Anticipated trial start date

2018 Year 09 Month 01 Day

Last follow-up date

2023 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

2018 Year 11 Month 10 Day

Last modified on

2023 Year 04 Month 07 Day



Link to view the page

Value
https://center6.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