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.: PACTR201608001710307 Date of Approval: 10/07/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Safety and Efficacy of Ketamine-Dexmedetomidine versus Ketamind-Propofol Combinations for Sedation in Patients after Coronary Artery Bypass Graft Surgery
Official scientific title Safety and Efficacy of Ketamine-Dexmedetomidine versus Ketamind-Propofol Combinations for Sedation in Patients after Coronary Artery Bypass Graft Surgery
Brief summary describing the background and objectives of the trial Comparison show - 10% patient had hypotension in group I and 30% in-group II that show significant decrease in mean arterial blood pressure in group II when compared to group I. - 15% patient had bradycardia and 30% in-group II that show borderline significant decrease in heart rate in group II when compared to group I. - No patients developed nausea and vomiting in both groups.
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 Graft surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/01/2013
Actual trial start date 01/01/2013
Anticipated date of last follow up 31/07/2016
Actual Last follow-up date 31/08/2016
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table from a statistics book allocation was determined by the holder of sequence Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ketamine dexmedetomidine received ketamine + dexmedetomidine 1.0 microg/kg over 20 minutes and then 0.2 to 0.7 microg/kg/h during the period of assissted ventilation received ketamine + dexmedetomidine 1.0 microg/kg over 20 minutes and then 0.2 to 0.7 microg/kg/h 35 Active-Treatment of Control Group
Experimental Group ketamine propfol received Ketamine + propofol 1 mg/Kg bolus followed by 25-50 micg/Kg/min during the period of assissted ventilation received Ketamine + propofol 1 mg/Kg bolus followed by 25-50 micg/Kg/min 35 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients 40-60 years old hemodynamically stable with normal or moderately impaired left ventricular function ejection fraction (EF) > 40%; who underwent elective coronary artery bypass graft surgery under high-dose opioid anesthesia on mechanical ventilation - Patient refusal. - Pregnant patients. - Patients with neurologic disease - Patients with liver or renal insufficiency - Hemodynamic instability both intraoperative, post bypass or postoperative - Patients on high dose vasopressor or inotropes. - Patients need muscle relaxant. - Patients need postoperative mechanical ventilation more than 24 hours. 40 Year(s) 60 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 01/06/2016 Tanta Univercity, Faculty of Medicine, Research Ethics Committee, Quality Assurance Unit
Ethics Committee Address
Street address City Postal code Country
Elbahr Street Tanta Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome compare ketamine-propofol (KP) and ketamine-dexmedetomidine (KD) combinations for sedation and analgesia in patients after coronary artery bypass graft surgery Sedation level assessed using Ramsey Sedation Scale Pain assessed using adult non verbal pain score (30) Postoperative pain was assessed over 24 h. using 10-cm Numerical Pain Rating scale (NPRS)(31
Secondary Outcome hemodynamics, total fentanyl dose, duration of mechanical ventilation and any adverse outcome heart rate, blood pressure total fentanyl dose duration of mechanical ventilation and any adverse outcome
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta Univercity Hospital Elbahr Street Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta Univercity hospital anaesthesia department and Cardiothoracic surgery departement Elbahr Street Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta Univercity hospital anaesthesia department and Cardiothoracic surgery departement Elbahr Street Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mona Mohammed Mogahed Elmoatasem Street Tanta Egypt
Ghada Fouad EL-baradey Omar Ibn AbdElaziz Street Tanta Egypt
Mohamed Shafik Elkahwagy Elmoatasem Street Tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mona Mogahed monamogahedfr@hotmail.com 00201145130150 Elmoatasem
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of anesthesia and surgical Intensive care Faculty of medicine Tanta University
Role Name Email Phone Street address
Principal Investigator Ghada EL-baradey ghadadido@yahoo.com 00201091206301 Omar Bin AbdElaziz Street
City Postal code Country Position/Affiliation
Tanta Egypt Associate professor of anesthesia and surgical intensive care unit
Role Name Email Phone Street address
Principal Investigator Mohamed Elkahwagy m_elkahwagy2005@hotmail.com 00201277719212 Elmoatasem
City Postal code Country Position/Affiliation
Tanta Egypt Lecturer of cardiothoracic surgery Faculty of medicine Tanta University
REPORTING
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