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.: PACTR201404000804408 Date of Approval: 31/03/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Desflurane versus Sevoflurane in cirrhotic patients undergoing liver resection
Official scientific title Desflurane versus Sevoflurane in cirrhotic patients undergoing liver resection
Brief summary describing the background and objectives of the trial Hepatocellular carcinoma (HCC) 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. Desflurane, the relatively new inhalational agent, is compared to Sevoflurane in terms of presevation of liver and renal functions.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Digestive System,Patients undergoing liver transplantation,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/06/2013
Actual trial start date 01/06/2013
Anticipated date of last follow up 30/06/2014
Actual Last follow-up date 30/06/2014
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Completed
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 =4) 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 Desflurane group 1 MAC Duration of operation INHALATION 25
Experimental Group Sevoflurane 1 MAC Duration of operation INHALATION 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients Child A cirrhotic patient. Oesophageal disease Re-operation. History of allergic reaction to drugs used. Recent anaesthesia (within 7 days). Severe bleeding intra-operatively and Haemodynamic unstability. 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
Yes 01/02/2014 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 tests Pre and postoperatively
Secondary Outcome Renal function tests Pre and postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Liver Institute, Menoufiya University Yassin abd elghafar street Al Menoufiya Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National Liver Institute, Menoufiya University Yassin abd elghafar street Al Menoufiya Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Liver Institute, Menoufiya University Yassin abd elghafar street Al Menoufiya Egypt University
COLLABORATORS
Name Street address City Postal code Country
MANSOUR ABOU HUSSEIN Gleem Alexandria Egypt
Ahmed el attar Anaesthesia depart, Faculty of Medicine Alexandria Egypt
Khaled Ahmed Yassen Yassin abd elghafar street Al Menoufiya Egypt
RAGAB BELTAGI Anaesthesia depart, Faculty of Medicine Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ahmed elattar a_attar@link.net 00201222144835 Anaesthesia department-faculty of medicine
City Postal code Country Position/Affiliation
Alexandria Egypt Professor of Anesthesia 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 Khaled Yassen kyassen61@hotmail.com 002-01063080170 Kafr abdo
City Postal code Country Position/Affiliation
Alexandria Egypt Professor of Anesthesia and Intensive Care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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