UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031803 |
|---|---|
| Receipt number | 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 21:55:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hani_taman@yahoo.com
Sponsor or person
Institute
MANSOURA FACULTY OF MEDICINE, MANSOURA, EGYPT
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036307
