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.: PACTR201512001375334 Date of Approval: 03/12/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title MicroRNA differential profiling in hepatitis C patients undergoing major surgeries: Propofol versus sevoflurane anesthesia.
Official scientific title MicroRNA differential profiling in hepatitis C patients undergoing major surgeries: Propofol versus sevoflurane anesthesia.
Brief summary describing the background and objectives of the trial This study will investigate the microRNA expression changes induced by sevoflurane and propofol and their effects on liver-function changes during perioperative periods. Methods: The study will be designed as randomized controlled study, it will be carried out in Alexandria Main University Hospital on 200 adult patients, ASA physical status III - IV, scheduled for major surgery with expected excessive blood loss (spinal fixation, maxillomandibular fractures, pelvic or compound femur fractures) under general anesthesia (GA), after approval of the ethical committee and having an informed written consent from every patient. All patients will be subjected to the same anesthetic protocol for induction of GA. Patients will be randomly divided into four equal groups; groups SC and PC included chronic hepatitis C (CHC) patients where SC group are patients receiving Sevoflurane, and PC group are patients receiving Propofol anesthesia. While S and P groups included non- hepatitis patients; S group are patients receiving Sevoflurane and P group are patients receiving Propofol. Anesthesia in Group S and SC patients will be maintained by sevoflurane, while anesthesia in Group P and PC patients will be maintained by propofol infusion. Blood samples were analyzed for PT, PTT and liver enzymes. Serum samples will be analyzed for microRNA.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,HCV
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 07/12/2015
Actual trial start date
Anticipated date of last follow up 15/02/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Not yet 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 Simple randomization using a randomization table from a statistics book Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group propofol induction induction and maintenance 50 Active-Treatment of Control Group
Experimental Group sevoflurane induction induction and maintenance 50
Control Group propofol HCV NEGATIVE induction induction and maintenance 50
Control Group sevoflurane HCV negative induction induction and maintenance 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA II III Major surgery ASA I,IV CANCER PATIENTS BLOOD DISEASES 20 Year(s) 50 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 31/12/2014 ethics committe faculty of medicine Alexandria university
Ethics Committee Address
Street address City Postal code Country
al azerita square alexandria 0000 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome effect of study drugs on micro RNA immediate postoperative
Secondary Outcome effect of study drugs on liver functions immediate postoperative 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria university hospital el azerita square alexandria 0000 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alexandria univesity el azerita square alexandria 0000 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Science and Technology Development Funds(STDF) roxy cairo 0000 Egypt Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Hala demerdash pharos university alexandria 0000 Egypt
emad aerida alexandria university alexandria 0000 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ola zanaty olazanaty@yahoo.com +0201148800811 el azerita square
City Postal code Country Position/Affiliation
alexandria 0000 Egypt assistant professor
Role Name Email Phone Street address
Public Enquiries ola zanaty olazanaty@yahoo.com +0201148800811 el azerita square
City Postal code Country Position/Affiliation
alexandria 0000
Role Name Email Phone Street address
Public Enquiries ola zanaty olazanaty@yahoo.com +0201148800811 el azerita square
City Postal code Country Position/Affiliation
alexandria 0000
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