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.: PACTR201909557694667 Date of Approval: 20/09/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Intraoperative effects of dexmedetomidine infusion in adult living donors undergoing hepatic resections for liver transplantation: A randomized control trial.
Official scientific title Intraoperative effects of dexmedetomidine infusion in adult living donors undergoing hepatic resections for liver transplantation: A randomized control trial.
Brief summary describing the background and objectives of the trial The aim in this prospective randomized clinical trial was to investigate the ability of intraoperative infusion of dexmetomidine (Dex) in the protection of the hepatic parenchyma and its effect on the general anaesthetic requirements in adult living donors undergoing hepatic resections for liver transplantation(LDLT) .
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2015
Actual trial start date 01/01/2015
Anticipated date of last follow up 01/01/2018
Actual Last follow-up date 01/01/2018
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL committee of principles and values colleague of medicine Menoufeya university
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group dexmedetomidine group dex group dex group (group D; n = 20) that received a continuous infusion of (0.8 μg kg-1h-1) of dex (Percedex; Hospira, Inc., Lake Forest, IL 60045 USA). Dexmedetomidine 200 mcg vial was diluted to a concentration of 4μg /ml and infusion started after the induction of anesthesia and continued till the end of surgery. infusion started after the induction of anesthesia and continued till the end of surgery. infusion started after the induction of anesthesia and continued till the end of surgery. 20
Control Group control group the same volume and same rat of normal saline that equivalent to the previous calculated dose of dexmedetomidine infusion started after the induction of anesthesia and continued till the end of surgery. the same volume and same rat of normal saline that equivalent to the previous calculated dose of dexmedetomidine infusion started after the induction of anesthesia and continued till the end of surgery. 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All donors fulfilled the eligibility criteria for donation including a within normal liver histology and a volumetric study of the whole liver and the right lobe.Age 18-45 years old, ASA I, normal liver functions, coagulation profiles and normal renal functions. inability to give written consent, hemoglobin level < 10 g/dl. Any contraindication for donation. Adult: 19 Year-44 Year 19 Year(s) 45 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 01/01/2015 Menoufiya University Natioanl LIver Institute Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
menoufeya university faculty of medicine menoufeya university 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome we primary investigated the ability of intraoperative infusion of dex in adult living donors undergoing hepatic resections for liver transplantation in the protection of the hepatic parenchyma assessed by laboratory data , including ALT, AST, bilirubin, INR, and lactate (reflecting the degree of hepatocellular injury, elimination and synthetic dysfunctions) and serum ICAM-1 level measurement (reflecting the magnitude of the endothelial cell damages and the severity of inflammatory reactions . measured at baseline, post resection, end of surgery and on POD3.
Secondary Outcome secondary we evaluated the effects of Dex infusion on the general anaesthetic requirements. intraoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
national liver institute menofeya university menoufeya university menoufeya 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
national liver institute menofeya university national liver institute menofeya university sheben el kom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor national liver institute menoufeya university menoufeya university menoufeya university 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
eman sayed ibrahim national liver institute menoufeya university sheben el kom 32511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator eman sayed emansayed825@gmail.com 01282271464 5 abdallah esmael nasser elthawra haram
City Postal code Country Position/Affiliation
giza 125211261 Egypt associate prof of anesthesia and ICU
Role Name Email Phone Street address
Public Enquiries hesham maged heshammaged2005@yahoo.com 0123548537 hassan abdallah giza
City Postal code Country Position/Affiliation
giza 125211261 Egypt Dr
Role Name Email Phone Street address
Scientific Enquiries hatem amin hatemamin456@gmail.com 01016303518 menoufia
City Postal code Country Position/Affiliation
menoufia 32511 Egypt professsor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes i will published individual participate date and share it throw journal that PubMed indexed Statistical Analysis Plan i will published individual participate date and share it throw journal that PubMed indexed I am responsible for participate data share
URL Results Available Results Summary Result Posting Date First Journal Publication Date
PubMed and Scopus index journals No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information