UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040608
Receipt number R000046343
Scientific Title Safety and efficacy of sedation with a combination of midazolam and dexmedetomidine for endoscopic retrograde cholangiopancreatography in very elderly patients : A single arm trial
Date of disclosure of the study information 2020/06/01
Last modified on 2020/06/01 12:59:58

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Basic information

Public title

Safety and efficacy of sedation with a combination of midazolam and dexmedetomidine for endoscopic retrograde cholangiopancreatography in very elderly patients : A single arm trial

Acronym

Safety and efficacy of sedation with a combination of midazolam and dexmedetomidine for endoscopic retrograde cholangiopancreatography in very elderly patients : A single arm trial

Scientific Title

Safety and efficacy of sedation with a combination of midazolam and dexmedetomidine for endoscopic retrograde cholangiopancreatography in very elderly patients : A single arm trial

Scientific Title:Acronym

Safety and efficacy of sedation with a combination of midazolam and dexmedetomidine for endoscopic retrograde cholangiopancreatography in very elderly patients : A single arm trial

Region

Japan


Condition

Condition

biliary pancreatic disease

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Safety and efficacy of sedation with a combination of midazolam and dexmedetomidine for endoscopic retrograde cholangiopancreatography in very elderly patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

amount of midazolam

Key secondary outcomes



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

a combination of midazolam and dexmedetomidine for endoscopic retrograde cholangiopancreatography

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

80 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

diagnostic or therapeutic ERCP in patients aged over 80 years

Key exclusion criteria

HR<50 bpm
baseline blood pressure<80 mmHg
emergency case
history of intolerance to benzodiazepines
dementia

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Takuya
Middle name
Last name Takayanagi

Organization

International University of Health and Welfare Atami Hospital

Division name

Department of Gastroenterology

Zip code

4130012

Address

Shizuoka prefecture atami city east coast town 13-1

TEL

0557819171

Email

t_takayanagi1987@yahoo.co.jp


Public contact

Name of contact person

1st name Takuya
Middle name
Last name Takayanagi

Organization

International University of Health and Welfare Atami Hospital

Division name

Department of Gastroenterology

Zip code

4130012

Address

Shizuoka prefecture atami city east coast town 13-1

TEL

09079132779

Homepage URL


Email

t_takayanagi1987@yahoo.co.jp


Sponsor or person

Institute

International University of Health and Welfare

Institute

Department

Personal name



Funding Source

Organization

no

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

International University of Health and Welfare

Address

Tokyo metropolitan minato ward akasaka4-1-26 Tokyo Akasaka campus 11F

Tel

0355743900

Email

yumi.inagaki@iuhw.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

2020 Year 06 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

Suspended

Date of protocol fixation

2020 Year 05 Month 08 Day

Date of IRB

2020 Year 05 Month 08 Day

Anticipated trial start date

2020 Year 06 Month 01 Day

Last follow-up date

2025 Year 05 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

2020 Year 06 Month 01 Day

Last modified on

2020 Year 06 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046343


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name