UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of side-effects of dexmedetomidine during endoscopic submucosal dissection
Title of the study (Brief title)	Side-effects of dexmedetomidine 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 hydration for 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	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Hydration with maintenance fluid
Interventions/Control_2	only maintenance fluid
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)hypovolemic 5)severe or uncontroallable respiratory disease 6)acute alcoholoic addiction
Target sample size	120

Research contact person
Name of lead principal investigator	Naohiko Akimoto
Organization	Nippon Medical School Chiba-Hokuso Hospital
Division name	Department of Gastroenterology
Address	1715 Kamagari, Inzai, Chiba, Japan
TEL	0476-99-1111
Email	s03-004an@nms.ac.jp

Public contact
Name of contact person	Naohiko Akimoto
Organization	Nippon Medical School Chiba-Hokuso Hospital
Division name	Department of Gastroenterology
Address	1715 Kamagari, Inzai, Chiba, Japan
TEL	0476-99-1111
Homepage URL
Email	s03-004an@nms.ac.jp

Sponsor
Institute	Nippon Medical School
Institute
Department

Funding Source
Organization	Nippon Medical School
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 08 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 08 Day
Anticipated trial start date	2017 Year 08 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 22 Day
Last modified on	2018 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032920