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.: PACTR201402000759256 Date of Approval: 02/02/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title TARGET-CONTROLLED INFUSION OF PROPOFOL-FENTANYL VERSUS DESFLURANE ON HEPATOCELLULAR INTEGRITY IN CIRRHOTIC PATIENTS UNDERGOING MAJOR HEPATIC RESECTION
Official scientific title EFFECT OF TARGET-CONTROLLED INFUSION OF PROPOFOL-FENTANYL VERSUS DESFLURANE ON HEPATOCELLULAR INTEGRITY IN CIRRHOTIC PATIENTS UNDERGOING MAJOR HEPATIC RESECTION
Brief summary describing the background and objectives of the trial Hepatocellular carcinoma (HCC) ranks fifth among the most prevalent cancers in the world and is the third most common cause of cancer related mortality. It is frequently found in patients with chronic liver disease resulting from infection with hepatitis C virus (HCV) .Liver resection is still the first choice for treatment of HCC, even at the intermediate or advanced stages. This surgery may be followed by clinical or subclinical hepatocellular derangements, metabolic insufficiency, hemodynamic changes and impairment of pulmonary gas exchange, which could lead to postoperative hepatic and multiorgan dysfunction. Target controlled infusion (TCI) of opioids and propofol were advocated to provide anaesthesia for major liver resection aiming to fasten patient recovery with minimal stay in the postoperative intensive care. On the other hand, Desflurane has been reported to be more innocent than other volatile agents. It is almost resistant to biotransformation and only 0.01% can be metabolized.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Digestive System,Hepatocellular carcinoma,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/02/2012
Actual trial start date 01/03/2012
Anticipated date of last follow up 31/03/2014
Actual Last follow-up date 31/03/2014
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Completed
Publication URL http://dx.doi.org/10.4172/2155-6148.1000485
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 =4) and the block size was not variable Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group TARGET CONTROLLED INFUSION PROPOFOL FENTANYL 4 hours Target controlled infusion 25
Experimental Group INHALATIONAL 1 MAC 4 hours INHALATION 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patient. Cirrhotic patient. Child A classified patient. - history of esophageal disease. - Patients undergoing re-operation. - history of allergic reactions to drugs. - recent anaesthetia (within the previous 7 days). - Patients who bled profusely during their operation, who are haemodynamically unstable, or who need inotropic support. - preoperative renal dysfunction 21 Year(s) 73 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
No 01/01/2012 National Liver Institute IRB
Ethics Committee Address
Street address City Postal code Country
Yassin abd elghafar street SHEBIN el kom Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Liver function test [glutathione S transferase] Preoperative,immediate postoperative,48 hours postoperative
Primary Outcome Kidney function test [microalbumin in urine] Preoperative,immediate postoperative,48 hours postoperative
Secondary Outcome Hemodynamic parameters[corrected flow time,stroke volume,systemic vascular resistance Intraoperative 24 and 48 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Liver Institute, Menoufiya University Yassin abd elghafar street SHEBIN el kom Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Anaesthesia department Faculty of medicine Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Amr el safty Smouha Alexandria Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Amr el safty Smouha Alexandria Egypt
Khaled Ahmed Yassen Yassin abd elghafar street SHEBIN el kom Egypt
Ahmed el attar Anaesthesia depart, Faculty of Medicine Alexandria Egypt
Ragab beltagui Anaesthesia depart, Faculty of Medicine Alexandria Egypt
Mohamed hussein abdulla Anaesthesia depart, National liver institute SHEBIN el kom Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator amr elsafty elsaftyamr@yahoo.com 002-01223990743 Elnasr-infront green plaza
City Postal code Country Position/Affiliation
Alexandria Egypt Doctor of Anaesthesia
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 ahmed elattar a_attar@link.net 002-01222144835 Anaesthesia department-faculty of medicine
City Postal code Country Position/Affiliation
Alexandria Egypt Professor of Anaesthesia
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