UMIN-CTR Clinical Trial

Basic information
Public title	Hepatic protective effect of Dexmedetomidine after partial hepatectomy surgery: a prospective controlled study.
Acronym	Hepatic protective effect of Dexmedetomidine after partial hepatectomy surgery: a prospective controlled study.
Scientific Title	Hepatic protective effect of Dexmedetomidine after partial hepatectomy surgery: a prospective controlled study.
Scientific Title:Acronym	Hepatic protective effect of Dexmedetomidine after partial hepatectomy surgery: a prospective controlled study.
Region	Africa

Condition
Condition	CONTROLLED TRIAL
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	assess the protective effect of dexmedetomedine on liver after partial hepatectomy using inflow occlusion.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	EVALUATION THE PROTECTIVE EFFECT OF DEXMEDETOMEDINE ON HEPATIC FUNCTION AFTER PARTIAL HEPATECTOMY
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Behavior,custom
Interventions/Control_1	dexmedetomidineis dissolved in 0.9% sodium chloride with the concentration of 4 mg ml and infused at 0.3 mg/kg/ h.
Interventions/Control_2	0.9% sodium chloride is infused at 4 ml/kg/ h.
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1- ASA II/III 2- planned for partial hepatectomy
Key exclusion criteria	1-patient refusal 2- any renal diseases 3- cardiac ejection fraction less than 40% 4- myocardial infarction within 3 months, or any anginal pain within 48 h 5- fulminant hepatitis 6- pulmonary dysfunction
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name HANI I TAMAN
Organization	MANSOURA FACULTY OF MEDICINE, MANSOURA, EGYPT
Division name	ANAESTHESIOLOGY DEPARTMENT
Zip code
Address	12, ELGOMHORIA STREET, MANSOURA, EGYPT
TEL	020502261333
Email	mfm@mans.edu.eg

Public contact
Name of contact person	1st name Middle name Last name HANI IBRAHIM TAMAN
Organization	MANSOURA FACULTY OF MEDICINE
Division name	ANAESTHESIOLOGY DEPARTMENT
Zip code
Address	14, GEHAN STREET, MANSOURA, EGYPT
TEL	020507484774
Homepage URL
Email	hani_taman@yahoo.com

Sponsor
Institute	MANSOURA FACULTY OF MEDICINE, MANSOURA, EGYPT
Institute
Department

Funding Source
Organization	MANSOURA FACULTY OF MEDICINE, MANSOURA, EGYPT
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
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

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 25 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	2015 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 19 Day
Last modified on	2018 Year 03 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036307

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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