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.: PACTR201701001983201 Date of Approval: 18/01/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of isoflurane on diastolic dysfunction
Official scientific title ECHOCARDIOGRAPHIC EVALUATION OF THE EFFECTS OF INCREASE DEPTH OF ANESTHESIA BY ISOFLURANE ON LEFT VENTRICULAR RELAXATION INDICES IN PATIENTS WITH DIASTOLIC DYSFUNCTION IN OPEN HEART SURGERIES
Brief summary describing the background and objectives of the trial Diastolic dysfunction has been increasingly recognized as an important cause of congestive heart failure(CHF) and resultant mortality and morbidity. About 50% patients with CHF have ¿diastolic heart failure¿ in spite of a normal systolic function with preserved ejection fraction. Patients with ischemic heart disease, hypertrophic cardiomyopathy and systemic hypertension may have signs of CHF due to diastolic dysfunction in the absence of preceding impairment of systolic function. Diastolic dysfunction is highly predictive of adverse events after myocardial infarction. Determination of the suitable depth of anesthesia for patients with diastolic dysfunction will decrease the perioperative morbidity, mortality and hospital stay. In this study we will evaluate the effect of depth of anesthesia by isoflurane on left ventricular diastolic function in patients with impaired left ventricular relaxation due to ischemic heart disease undergoing on pump coronary artery bypass graft surgery using transesophageal Doppler echocardiography.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ischemic heart disease with diastolic dysfunction.,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/03/2017
Actual trial start date 01/02/2017
Anticipated date of last follow up 01/01/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 54
Actual target sample size (number of participants)
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dose of isoflurane that cause bispectral index (BSI) reading = 60 Once once for 20 min before skin incision readings will be reported before and after isoflurane dose changing, the patient act as a control for himself 54
Experimental Group Dose of isoflurane that cause bispectral index (BSI) reading = 40 Once once for 20 min before skin incision readings will be reported at isoflurane dose that cause BSI reading = 40 54
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Non-emergent coronary artery bypass grafting surgery. Left ventricular ejection fraction of 45% or more. Grade 1 diastolic dysfunction. Cardiac valvular pathology. Myocardial infarction within 4 weeks. Body mass index greater than 40 kg/m2. Pacemaker therapy. Left bundle branch block or Atrial fibrillation. Esophagitis or esophageal varices. Hypertrophic obstructive cardiomyopathy or infiltrative myocardial disease. Emergency CABG and patients coming on inotropes or mechanical ventilation. 18 Year(s) 80 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 13/02/2017 Ethics committee of faculty of medicine, Fayoum University.
Ethics Committee Address
Street address City Postal code Country
Said Soliman Street Fayoum 63514 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Trans mitral flow velocity profile measured by by pulsed wave Doppler (PWD). 1) One hour before going to surgery as a baseline reading by trans-esophageal echocardiography (TTE). 2) At bi-spectral index (BIS) 60-65. 3) At BIS 40-45.
Secondary Outcome Pulmonary vein flow velocity profile measured by PWD. 1) One hour before going to surgery as a baseline reading by trans-esophageal echocardiography (TTE). 2) At bi-spectral index (BIS) 60-65. 3) At BIS 40-45.
Secondary Outcome Tissue Doppler imaging of the mitral annulus. 1) One hour before going to surgery as a baseline reading by trans-esophageal echocardiography (TTE). 2) At bi-spectral index (BIS) 60-65. 3) At BIS 40-45.
Secondary Outcome Hear rate 1) Before induction of anesthesia (after insertion of all monitors) as baseline reading. 2) At BIS 60-65. 3) At BIS 40-45.
Secondary Outcome Mean arterial pressure 1) Before induction of anesthesia (after insertion of all monitors) as baseline reading. 2) At BIS 60-65. 3) At BIS 40-45.
Secondary Outcome central venous pressure 1) Before induction of anesthesia (after insertion of all monitors) as baseline reading. 2) At BIS 60-65. 3) At BIS 40-45.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fayoum University hospital Said Soliman St., Fayoum University, Fayoum Fayoum 63514 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Fayoum University hospital Said Soliman St., Fayoum University, Fayoum Fayoum 63514 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fayoum University hospital Said Soliman St., Fayoum University, Fayoum Fayoum 63514 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Hany Mahmoud Yassin 303t, Hadaek Al-Ahram, Giza Giza 12572 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hany Yassin hmy00@fayoum.edu.eg 0020 1111 3636 02 303t, Hadaek Al-Ahram, Giza
City Postal code Country Position/Affiliation
Giza 12572 Egypt Lecturer of anesthesia and ICU, faculty of medicine, Fayoum University
Role Name Email Phone Street address
Principal Investigator Hany Yassin hmy00@fayoum.edu.eg 0020 1111 3636 02 303t, Hadaek Al-Ahram, Giza
City Postal code Country Position/Affiliation
Giza 12572 Egypt Lecturer of anesthesia and ICU, faculty of medicine, Fayoum University
Role Name Email Phone Street address
Public Enquiries Atef Elsebaie atefelsebaie@yahoo.com 00201112182274 1925, abd elfatah Haredy street, 2 nd district, 7 th area
City Postal code Country Position/Affiliation
6 th October city. 12573 Egypt Specialist anesthetist at national heart institute, Giza, Egypt.
Role Name Email Phone Street address
Scientific Enquiries Atef Elsebaie atefelsebaie@yahoo.com 00201112182274 1925, abd elfatah Haredy street, 2 nd district, 7 th area
City Postal code Country Position/Affiliation
6 th October city 12573 Egypt Specialist anesthetist at national heart institute, Giza, Egypt.
REPORTING
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