![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | 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 |
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 |
|
Condition | ||
Condition | CONTROLLED TRIAL | |
Classification by specialty |
|
|
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 |
|
||
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
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 | |
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 |
|
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 |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
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 |
|
||||||
Last modified on |
|
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 |