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.: PACTR201605001606658 Date of Approval: 28/04/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ketofol versus sevoflurane for maintenance of aesthesia in paediatric cardiac catheterization . A prospective double blind study.
Official scientific title Ketofol versus sevoflurane for maintenance of aesthesia in paediatric cardiac catheterization .
Brief summary describing the background and objectives of the trial Background : Pediatric cardiac anesthesia involves anaesthetizing very small children with complex congenital heart disease. Sevoflurane provides the advantage of rapid induction of anesthesia with short recovery time. Ketofol is a neologism coined to refer to the combination of ketamine and propofol mixed together in one syringe. Ketamine and propofol have opposing influences on blood pressure, heart rate, and SVR. Aim of the work : to compare the effectiveness and side effects of Ketofol versus sevoflurane for maintenance of aesthesia in pediatric cardiac catheterization.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Anaesthesia,Circulatory System,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/08/2014
Actual trial start date 01/08/2014
Anticipated date of last follow up 30/11/2015
Actual Last follow-up date 30/11/2015
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
Recruitment status Completed
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 randomisation using computer software closed envlope Open-label(Masking Not Used)
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised simple randomisation using computer software closed envlope Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group K received ketofol mixture ketofol mixture (propofol, 4 mg/mL, and ketamine, 2 mg/mL) infusion rate propofol 25-50mic/kg/min and ketamine 12.5-25mic/kg/min for maintenance during the cathetrization 45
Experimental Group Group S received sevoflurane received sevoflurane 0.5¿1 MAC during the cathetrization 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
American Society of Anesthesiologists grade II to III elective cardiac catheterization Patients suffering major endocrinal, respiratory, renal or hepatic disease Patients requiring mechanical ventilation, or intravenous inotropic support were also excluded 1 Month(s) 4 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 26/08/2015 ethics committee faculty of medicine alexandria university
Ethics Committee Address
Street address City Postal code Country
el azerita square Faculty of Medicine, University of Alexandria, Egypt alexandria 0000 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome . The primary outcome was to compare the hemodynamic effects of sevoflurane and ketofol as maintenance anesthesia. A significant change more than 20%compared with baseline values for mean arterial blood pressure was defined as clinically important during cathetrization
Secondary Outcome to compare the side effects betwwen two groups during catherization and in recovery
Secondary Outcome and the incidence of agitation betwwen 2 groups on recovery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
alexandria university hospital el azerita square Faculty of Medicine, University of Alexandria, Egypt alexandria 0000 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
el Faculty of Medicine, University of Alexandria, Egypt el azerita square Faculty of Medicine, University of Alexandria, Egypt alexandria 0000 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor el Faculty of Medicine, University of Alexandria, Egypt el azerita square Faculty of Medicine, University of Alexandria, Egypt alexandria 0000 Egypt University
COLLABORATORS
Name Street address City Postal code Country
shahira el metainy el azerita square Faculty of Medicine, University of Alexandria, Egypt alexandria 0000 Egypt
rabab saber el azerita square Faculty of Medicine, University of Alexandria, Egypt alexandria 0000 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator shahira el metainy shelmetainy@yahoo.com +01223527804 el azerita square Faculty of Medicine, University of Alexandria, Egypt
City Postal code Country Position/Affiliation
alexandria 0000 Egypt Assistant Professor Anaesthesia and Surgical Intensive Care
Role Name Email Phone Street address
Public Enquiries shahira el metainy shelmetainy@yahoo.com +201223527804 el azerita square
City Postal code Country Position/Affiliation
alexandria 0000 Egypt assisstent proffessor department of Anesthesia
Role Name Email Phone Street address
Scientific Enquiries shahira el metainy shelmetainy@yahoo.com +201223527804 el azerita square
City Postal code Country Position/Affiliation
alexandria 0000 Egypt assisstent proffessor department of Anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information