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.: PACTR201402000758402 Date of Approval: 01/02/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Desflurane or propofol for Postoperative sedation of mechanically ventilated liver recipients.
Official scientific title : Desflurane versus propofol for Postoperative sedation of mechanically ventilated liver recipients.
Brief summary describing the background and objectives of the trial Mechanically ventilated liver recipients usually receive one or more sedative drugs which may affect haemodynamics, recovery profiles of each patient. The aim of this work is to compare haemodynamics, recovery profiles, postoperative side effects and costs of Desflurane and Propofol sedation for mechanically ventilated liver recipients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Digestive System,Mechanically ventilated liver recipients,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 31/03/2014
Actual Last follow-up date 31/03/2014
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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) 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 Desflurane group End-tidal concentration of 3 vol. % will be used initially, and this could be changed in steps of up to 0.5 vol. % to keep patient state index PSI 50-75. Start from arrival at the ICU to 2 hrs after tracheal extubation Desflurane will be delivered by a modified TEC-6 vaporizer (Dr¿ger Medical). 30
Experimental Group Propofol group Propofol infusions should be titrated to response (range 0.5¿6 mg / kg / h). Bolus doses of Propofol 40 mg Start from arrival at the ICU to 2 hrs after tracheal extubation. Propofol will start from arrival at the ICU to 2 h after tracheal extubation. 30
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 planned for weaning of ventilation and fulfilling criteria of extubation. - Preoperative breathlessness on physical exercise. - Any central nervous system disease. - Severe haemodynamic instability at the end of the operation. - Patients in need for re-operation. - 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 01/06/2013 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 Sedation status: 1-PSI 2-Ramsay score Every hour
Secondary Outcome Haemodynamic parameters Every hour till 2 hrs after extubation
Secondary Outcome Each patient's recovery profile 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
National Liver Institute, Menoufiya University Yassin abd elghafar street SHEBIN el kom 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 SHEBIN el kom Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Khaled Ahmed Yassen Yassin abd elghafar street SHEBIN el kom Egypt
Eman Sayed Ibrahim Yassin abd elghafar street SHEBIN el kom Egypt
Magda Fouaad Yehia Yassin abd elghafar street SHEBIN el kom Egypt
Emad Kamel Refaat Yassin abd elghafar street SHEBIN el kom Egypt
Neveen Mostafa Soliman Yassin abd elghafar street SHEBIN el kom Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Khaled Yassen kyassen61@hotmail.com 002-01063080170 Yassin abd elghafar street
City Postal code Country Position/Affiliation
SHEBIN el kom 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 Eman AWAAD emankamal85@hotmail.com 002-01288513282 Yassin abd elghafar street
City Postal code Country Position/Affiliation
SHEBIN el kom Egypt Doctor of Anaesthesia
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