UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy of dexmedetomidine for postoperative sedation in the ICU, after endoscopic submucosa dissection under general anesthesia.
Acronym	Safety efficacy of dexmedetomidine for postoperative sedation in the ICU, after endoscopic submucosa dissection under general anesthesia.
Scientific Title	Safety and efficacy of dexmedetomidine for postoperative sedation in the ICU, after endoscopic submucosa dissection under general anesthesia.
Scientific Title:Acronym	Safety efficacy of dexmedetomidine for postoperative sedation in the ICU, after endoscopic submucosa dissection under general anesthesia.
Region	Japan

Condition
Condition	cervical esophageal cancer pharyngeal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of dexmedetomidine between high dose and low dose for postoperative sedation, after endoscopic submucosal dissection under general anesthesia.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	respiration, hemodynamic, complication, RASS score, VRS, the number of sedatives and analgesics, the number of fentanyl IV-PCA, questionnair
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are 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	Hight dose of dexmedetomidine
Interventions/Control_2	Low dose of dexmedetomidine
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	To undergo ESD under general anesthesia. To keep inubated until the next morning in the intensive care unit. Consenting patients
Key exclusion criteria	ASA class >3. BMI <35. Routine oral administration of sedatives and analgesics. Drug allergy of dexmedetomidine
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Keisuke Yamaguchi
Organization	Juntendo university
Division name	anesthesiology
Zip code
Address	Hongo, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Chika Ishibashi
Organization	Juntendo university
Division name	Anesthesiology
Zip code
Address
TEL	03-3813-3111
Homepage URL
Email

Sponsor
Institute	Juntendo university
Institute
Department

Funding Source
Organization	non
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
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	順天堂大学医学部附属順天堂医院（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 02 Month 06 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	Terminated
Date of protocol fixation	2013 Year 02 Month 06 Day
Date of IRB	2013 Year 02 Month 14 Day
Anticipated trial start date	2013 Year 02 Month 14 Day
Last follow-up date	2015 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	2013 Year 02 Month 06 Day
Last modified on	2022 Year 04 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011690