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.: PACTR201711002757295 Date of Approval: 13/11/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Cardioprotective effects of Dexmedetomidine in patients with Ischemic Heart Disease
Official scientific title Cardioprotective effects of Dexmedetomidine in patients with Ischemic Heart Disease undergoing elective lumbar spine fixation
Brief summary describing the background and objectives of the trial Aim of the study: The aim of this study is to evaluate the cardioprotective effects of dexmedetomidine in patients with ischemic heart disease undergoing elective lumbar spine fixation under general anesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Circulatory System,patients with Ischemic Heart Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/06/2015
Actual trial start date 02/06/2015
Anticipated date of last follow up 01/01/2018
Actual Last follow-up date 01/01/2018
Anticipated target sample size (number of participants) 32
Actual target sample size (number of participants) 32
Recruitment status Closed to recruitment,follow-up continuing
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 closed sealed opaque envelops: closed sealed opaque envelops: Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group D dexmedetomidine (Precedex, Abbot Laboratories Inc., Abbot Park, IL, USA 2 ml ,200ug vial,100ug/ml) 1¿g/kg over 10 min before induction of anesthesia followed by maintenance infusion of 0.2-0.7 ¿g/kg dexmedetomidine (Precedex, Abbot Laboratories Inc., Abbot Park, IL, USA 2 ml ,200ug vial,100ug/ml) 1¿g/kg over 10 min before induction of anesthesia followed by maintenance infusion of 0.2-0.7 ¿g/kg dexmedetomidine (Precedex, Abbot Laboratories Inc., Abbot Park, IL, USA 2 ml ,200ug vial,100ug/ml) 1¿g/kg over 10 min before induction of anesthesia followed by maintenance infusion of 0.2-0.7 ¿g/kg/hr and will be stopped before skin closure. 16
Control Group Group S normal saline before induction of anesthesia in the same volume and rate, and will be stopped before skin closure. normal saline before induction of anesthesia in the same volume and rate, and will be stopped before skin closure. normal saline before induction of anesthesia in the same volume and rate, and will be stopped before skin closure. 16 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Patients(45 -65 years) ¿ Normal preoperative Troponine I and CKMB levels ¿ Patients on preoperative statin and B blockers 1. Patients with acute myocardial infarction, 2. Congestive heart failure 3. Heart block 4. Unstable angina 5. Significant arrhythmia 6. EF¿ 50% 7. Previous CABAG 8. Diabetic patients 9. Uncontrolled hypertension 10. Epileptic patients 11. Patients with known allergies to the studied drugs 12. Severe hepatic, renal, or CNS involvement 13. Pregnant 14. Patients on opioids or alcohol use 45 Year(s) 65 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 23/04/2017 fm-bsurec
Ethics Committee Address
Street address City Postal code Country
Beni-Suef governerate Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Troponin I 12 hours postoperatively
Secondary Outcome ECG every 12 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Beni-Suef University hospital Beni-Suef Beni-Suef Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor doaa rashwan Beni Sueif Governerate Beni Sueif Governerate 11391 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Hatem Elmoutaz Beni Sueif Governerate Beni Sueif Governerate 11391 Egypt
doaa rashwan Beni Sueif Governerate Beni Sueif Governerate 11391 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hatem Elmoutaz Mahmoud doaa_rashwan@hotmail.com 01011270763 Beni Sueif Governerate
City Postal code Country Position/Affiliation
Beni Sueif Governerate 11391 Egypt Assistant professor of anesthesia and |SICU
Role Name Email Phone Street address
Public Enquiries doaa rashwan doaa_rashwan@hotmail.com 01011270763 Beni Sueif Governerate
City Postal code Country Position/Affiliation
Beni Sueif Governerate 1139 Egypt Assistant professor Faculty of medicine, Beni Sueif University
Role Name Email Phone Street address
Scientific Enquiries doaa rashwan doaa_rashwan@hotmail.com 01011270763 Beni Sueif Governerate
City Postal code Country Position/Affiliation
Beni Sueif Governerate 11391 Egypt Assistant professor Faculty of medicine, Beni Sueif University
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