Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201408000872245 Date of Approval: 20/08/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Dexmedetomidine infusion during Adult Living Donor Liver Transplantation
Official scientific title Intraoperative Effect of Dexmedetomidine infusion during Adult Living Donor Liver Transplantation
Brief summary describing the background and objectives of the trial Liver transplantation is a long major operation that is characterized by hemodynamic instability and require high anesthetic drugs consumption including opioids and inhalational anesthetics. Trying to provide hemodynamic stability and decrease the anesthetic requirement may have a good impact on the newly transplanted graft function and on the patient recovery besides the decrease in the total anesthetic cost .we design this study to evaluate the effects of Intraoperative Dexmedetomidine infusion during Adult Living Donor Liver Transplantation
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Donor Liver Transplantation,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2013
Actual trial start date 01/10/2013
Anticipated date of last follow up 31/12/2014
Actual Last follow-up date 31/12/2014
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (block size of 4 and the block size was not variable) Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dexamedetomidine 0.5 mic/kg/hr (0.2 -0.7mic/kg/h) Intraoperative Intraoperative admission of Dexamedetomidine 20
Control Group Control Intraoperative Intraopertive Saline admission 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Model for End-Stage Liver Disease (MELD) score 12-20. Living donor liver transplant recipients with no severe haemodynamic instability, normoxia, normothermia and no major intraoperative events. Severe haemodynamic instability. Unwilling to participate in the study. 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/01/2014 Menoufyia University, National Liver Institute (NLI), IRB
Ethics Committee Address
Street address City Postal code Country
Yassin abd elghafar street Shebeen El.koom Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Anesthetic consumption End of surgery
Secondary Outcome Metabolic effects of dexmedetomidine Intraoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National liver institute Yassin abd elghafar street Shebeen El.koom Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National liver institute Yassin abd elghafar street Shebeen El.koom Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National liver institute Yassin abd elghafar street Shebeen El.koom Egypt University
COLLABORATORS
Name Street address City Postal code Country
KHALED Yassen Yassin abd elghafar street Shebeen El.koom Egypt
Eman sayed Yassin abd elghafar street Shebeen El.koom Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khaled yassen kyassen61@hotmail.com 002-010-63080170 Yassin abd elghafar street
City Postal code Country Position/Affiliation
SHEBIN el kom Egypt Professor of Anesthesiology and Intensive Care
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 002-01223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries eman sayed emansayed825@gmail.com 002-0482221729 Yassin abd elghafar street
City Postal code Country Position/Affiliation
SHEBIN el kom Egypt Lecturer of Anaesthesia and Intensive Care
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information