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.: PACTR201511001243895 Date of Approval: 18/08/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of anesthetics on left ventricular diastolic function in patient with diastolic dysfunction undergoing CABG
Official scientific title Effect of propofol versus isoflurane on left ventricular diastolic function in patient with diastolic dysfunction undergoing coronary artery bypass grafting
Brief summary describing the background and objectives of the trial Background: A strong association has been found between preoperative diastolic dysfunction and difficulty in weaning from cardiopulmonary bypass (CPB). The present study will compare the effects of propofol and isoflurane on left ventricular (LV) diastolic function in patients with diastolic dysfunction undergoing coronary artery bypass grafting (CABG). Methods: Sixty patients will be randomized to receive propofol anesthesia in group I or isoflurane anesthesia in group II. Trans-esophageal echocardiography (TEE) will be performed and LV diastolic function will be assessed by measuring early (E), late (A) diastolic velocities, E/A ratio, A wave duration, and deceleration time (DT) by pulsed wave doppler. Early (Em), late (Am) diastolic velocities of the mitral annulus, Em/Am ratio and isovolumetric relaxation time (IVRT) will be measured by tissue doppler. Furthermore, the pulmonary venous flow velocity will be measured where values for the peak systolic flow velocity (S), peak diastolic flow velocity (D), S/D ratio, peak reverse atrial flow velocity (Ar) and duration of reverse atrial flow (Ar dur) will be recorded. All data will be recorded the day before surgery as a baseline (T0), 5 minutes after sternotomy (T1), 5 minutes before aortic cannulation (T2) and 15 minutes after coming off CPB (T3).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,coronary artery bypass grafting,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 05/01/2015
Actual trial start date 06/01/2015
Anticipated date of last follow up 23/11/2015
Actual Last follow-up date 30/11/2015
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status 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 randomisation using a randomisation table created by a computer software program Central randomisation by phone/fax Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Propofol In the propofol group, induction of anesthesia will be done by propofol 1.5¿2 mg/kg and fentanyl 3-5µg/kg titrated according to hemodynamics. Tracheal intubation will be facilitated by giving cis-atracurium 0.1 mg/kg. Maintenance of anesthesia will be done by a continuous infusion of propofol 4-6 mg. kg-1. h-1, and cis-atracurium 2 µg. kg-1. min-1. 30
Experimental Group Isoflurane In the isoflurane group, induction of anesthesia will be done as above but will be maintained with isoflurane 1MAC in 50% oxygen and air and cis-atracurium 2 µg. kg-1. min-1. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
60 ASA class II or III patients scheduled for CABG surgery by using CPB age > 75 years, left ventricular ejection fraction (LVEF) < 55%, pre-existing severe LV hypertrophy, cardiomyopathies, pre-existing valvular heart disease, grade II (pseudo-normal filling) and grade III (restrictive filling) diastolic dysfunction, preoperative atrial fibrillation , pericardial disease, emergency CABG, significant pulmonary disease and esophageal pathology. 45 Year(s) 75 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 04/11/2014 Ethical committee of Minoufiya Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
2Yaseen Abdel-Ghaffar st., Shebin Elkoam Shebin Elkoam Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome trans-mitral diastolic doppler flow profile, tissue doppler imaging (TDI) , pulmonary venous flow velocity All echocardiography data for statistical analysis will be recorded by TEE immediately after intubation as a baseline (T0), 5 min. after sternotomy (T1), 5 min. before aortic cannulation (T2) and 15 min. after coming off CPB (T3)
Secondary Outcome hemodynamic data (HR, MAP and CVP) will be recorded before induction of anesthesia as a baseline (T00), 5 min. after sternotomy (T1), 5 min. before aortic cannulation (T2) and 15 min. after coming off CPB (T3).
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Minoufiya University hospital 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam, Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Minoufiya University 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam, 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Minoufiya University 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam, 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Amany S Ammar 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam, 32511 Egypt
Khaled M Mahmoud 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam, 32511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khaled Mahmoud mahmoudk16@yahoo.com +201224884620 2 Yaseen Abdel-Ghaffar st.,
City Postal code Country Position/Affiliation
Shebin Elkoam 32511 Egypt Professor in anesthesiology, Minoufiya faculty of medicine
Role Name Email Phone Street address
Public Enquiries khaled Mahmoud mahmoudk16@yahoo.com +201224884620 2 Yaseen Abdel-Ghaffar st.,
City Postal code Country Position/Affiliation
Shebin Elkoam 32511 Egypt Professor in anesthesiology, Minoufiya faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries khaled Mahmoud mahmoudk16@yahoo.com +201224884620 2 Yaseen Abdel-Ghaffar st.,
City Postal code Country Position/Affiliation
Shebin Elkoam 32511 Egypt Professor in anesthesiology, Minoufiya faculty of medicine
REPORTING
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