UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033997
Receipt number R000038767
Scientific Title Evaluation of side-effects of dexmedetomidine depending on the volume of infusion during endoscopic submucosal dissection
Date of disclosure of the study information 2018/09/03
Last modified on 2021/09/28 16:39:50

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Basic information

Public title

Evaluation of side-effects of dexmedetomidine depending on the volume of infusion during endoscopic submucosal dissection

Acronym

Side-effects of dexmedetomidine depending on the volume of infusion during ESD

Scientific Title

Evaluation of side-effects of dexmedetomidine depending on the volume of infusion during endoscopic submucosal dissection

Scientific Title:Acronym

Side-effects of dexmedetomidine depending on the volume of infusion during ESD

Region

Japan


Condition

Condition

neoplastic lesions of esophagus, stomach and colon

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of 100ml or 1500ml infusion for preventing from the side-effects of dexmedetomidine during endoscopic submucosal dissection

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Side-effects (hypotension, bradycardia, respiratory depression)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

1500ml infusion

Interventions/Control_2

1000ml infusion

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who undergo ESD (esophagus, stomach and colon) with using DEX

Key exclusion criteria

1)uncontrollable diabetes
2)uncontrollable hypertension
3)uncontrollable heart disease
4)uncontrollable renal and/or urological diseases
5)hypovolemic
6)severe or uncontrollable respiratory disease
7)acute alcoholic addiction

Target sample size

56


Research contact person

Name of lead principal investigator

1st name Naohiko
Middle name
Last name Akimoto

Organization

Nippon Medical School Chiba-Hokuso Hospital

Division name

Department of Gastroenterology

Zip code

270-1694

Address

1715 Kamagari, Inzai, Chiba, Japan

TEL

0476-99-1111

Email

s03-004an@nms.ac.jp


Public contact

Name of contact person

1st name Takayoshi
Middle name
Last name Nishimoto

Organization

Nippon Medical School Chiba-Hokuso Hospital

Division name

Department of Gastroenterology

Zip code

270-1694

Address

1715 Kamagari, Inzai, Chiba, Japan

TEL

0476-99-1111

Homepage URL


Email

clubman629@nms.ac.jp


Sponsor or person

Institute

Nippon Medical School

Institute

Department

Personal name



Funding Source

Organization

own fund

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nippon Medical School Chiba-Hokuso Hospital IRB

Address

1715 Kamagari, Inzai, Chiba, Japan

Tel

0476-99-1111

Email

araraki@nms.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

2018 Year 09 Month 03 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 07 Day

Date of IRB

2018 Year 08 Month 07 Day

Anticipated trial start date

2018 Year 09 Month 03 Day

Last follow-up date

2023 Year 12 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 09 Month 02 Day

Last modified on

2021 Year 09 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038767


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name