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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031803
Receipt No. R000036307
Scientific Title Hepatic protective effect of Dexmedetomidine after partial hepatectomy surgery: a prospective controlled study.
Date of disclosure of the study information 2018/03/25
Last modified on 2018/03/19

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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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