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.: PACTR201801002824375 Date of Approval: 29/11/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison Between Amiodarone And Lidocaine With Magnesium Sulfate On Reperfusion Ventriculare Fibrillation After Aortic Cross Clamp Release
Official scientific title Comparison Between The Effect Of Amiodarone And Lidocaine With Magnesium Sulfate On Occurrenc Of Reperfusion Ventriculare Fibrillation After Aortic Cross Clamp Release On Aortic Valve Surgery
Brief summary describing the background and objectives of the trial This study will aim to compare between the efficacy of a single dose of amiodarone and lidocaine with magnesium sulfate by the way of pump circuit 3 minutes before ACC release and compare the results with normal saline as placebo in a randomized, double-blinded, controlled trial.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Circulatory System,reperfusion ventricular fibrillation before aortic cross clamp release
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/01/2016
Actual trial start date 15/02/2017
Anticipated date of last follow up 15/11/2017
Actual Last follow-up date 15/12/2017
Anticipated target sample size (number of participants) 87
Actual target sample size (number of participants) 87
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
nil known Mohammed Abbas Mohammed,Hatem El Moutaz Mahmoud,Ahmed Mostafa El-Shaarawy and Hazem Abd El-whab
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 computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group amiodarone 300 mg over 30 seconds 29 Patients will receive 300 mg amiodarone (6ml diluted with 19ml saline) intravenously as a bolus by the way of pump circuit, 3 minutes before aortic cross clamp release. 29
Experimental Group lidocaine 2% and magnesium sulfate 100 mg lidocaine 2% and 2 g magnesium sulfate over 30 seconds 29 Patients will receive 100 mg lidocaine 2% and 2 g magnesium sulfate (25 ml)injected intravenously by the way of pump circuit, 3 minutes before aortic cross clamp release. 29
Control Group normal saline over 30 seconds 29 Patients will receive 25 ml normal saline intravenously as a bolus by the way of pump circuit, 3 minutes before aortic cross clamp release. 29 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Patient with aortic valve disease ¿History of treatment with digoxin, amiodarone, or lidocaine (including cardiopulmonary resuscitation) ¿Contraindications to amiodarone (sick sinus syndrome, atrioventricular conduction abnormalities, thyroid disease, interstitial lung disorders, renal or liver disease, and known allergic or toxic reactions to amiodarone) ¿Combined cardiac surgery, and emergent operation. 18 Year(s) 70 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 09/10/2017 FM-BSU REC
Ethics Committee Address
Street address City Postal code Country
Mohamed Hassan St.¿ El Shamla St.¿ AL SHAMLAH¿ Bani Sweif, Beni Suef Governorate Beni Suef 62511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome incidence of VF requiring defibrillation during 30 minutes after aortic cross clamp release during 30 minutes
Secondary Outcome number of defibrillation needed during 30 minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
department of Anesthesiology, faculty of medicine, Beni-Suef University Mohamed Hassan St.¿ El Shamla St.¿ AL SHAMLAH¿ Bani Sweif, Beni Suef Governorate Beni Suef 62511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine, Beni Suef Univeristy Mohamed Hassan St.¿ El Shamla St.¿ AL SHAMLAH¿ Bani Sweif, Beni Suef Governorate Beni Suef 62511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine, Beni Suef Uneversity Mohamed Hassan St.¿ El Shamla St.¿ AL SHAMLAH¿ Bani Sweif, Beni Suef Governorate Beni Suef 62511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr.Hatem El Moutaz Mahmoud Mohamed Hassan St.¿ El Shamla St.¿ AL SHAMLAH¿ Bani Sweif, Beni Suef Governorate Beni Suef 62511 Egypt
Dr.Ahmed Mostafa El-Shaarawy Mohamed Hassan St.¿ El Shamla St.¿ AL SHAMLAH¿ Bani Sweif, Beni Suef Governorate Beni Suef 62511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammed Abbas www.peace222@yahoo.com +201110459899 Mohamed Hassan St.¿ El Shamla St.¿ AL SHAMLAH¿ Bani Sweif, Beni Suef Governorate
City Postal code Country Position/Affiliation
Beni Suef 62511 Egypt assistant Lecturer of Anesthesiology Faculty of Medicine, Beni - Suief University
Role Name Email Phone Street address
Public Enquiries Hazem Abd El-wahab hazem.hussien@med.bsu.edu.eg +201153517862 132 Al Rawda St, Beni Suef,Beni Suef Governorate,Egypt
City Postal code Country Position/Affiliation
Beni Suef 62511 Egypt Lecturer of Anesthesiology Faculty of Medicine, Beni - Suief University
Role Name Email Phone Street address
Scientific Enquiries Ahmed Mostafa El-Shaarawy drshaarawy@gmail.com +201141015584 7 Ali Abi Taleb st, Agouza, Giza, Egypt
City Postal code Country Position/Affiliation
Giza 62511 Egypt Lecturer of Anesthesiology Faculty of Medicine, Beni - Suief University
REPORTING
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