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.: PACTR201603000964133 Date of Approval: 08/12/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of Haemodynamic Effects of Propofol and Two Different Concentrations of Propofol-Ketamine Admixture: A Randomised Control Trial
Official scientific title Comparison of Haemodynamic Effects of Propofol and Two Different Concentrations of Propofol-Ketamine Admixture: A Randomised Control Trial
Brief summary describing the background and objectives of the trial Statement of Problem Propofol has become the most popular IV induction agent. However it commonly causes a significant drop in BP and has been associated with bradycardia. This is undesirable and limits its safe use in the critically ill and in those with limited physiological reserve. Induction with ketamine on the other hand is associated with an increase in both BP and pulse via stimulation of the sympathetic nervous system. These properties are desirable in a hypovolemia patient who still has a sympathetic reserve. However they limit the use of ketamine in those who have hypertension or ischaemic heart disease. Since the development of an ideal intravenous induction agent is not yet achieved, can a combination of existing ones, specifically propofol and ketamine give rise to an agent with better a haemodynamic risk profile, less contraindications and improved patient and caregiver satisfaction? It is also not yet established which ratio of propofol to ketamine would provide the best cardiovascular stability as an induction agent. Hypothesis The aim of this prospective, randomized, case control clinical study is to evaluate: 1. The hypothesis that propofol- ketamine induction prevents a greater than 20 % drop in blood pressure better than propofol alone at induction of anaesthesia. Objectives The main objectives of the research are: 1. To evaluate if ketofol has better a haemodynamic profile as an induction agent than propofol alone. 2. To evaluate how two different ratios of the ketamine propofol admixture behave. In other words how much ketamine is necessary to counterbalance the negative chronotropic and inotropic effect of propofol alone?
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/06/2014
Actual trial start date 06/08/2014
Anticipated date of last follow up 27/02/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
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 Block radomisation blocks of 9 Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Induction of anaethesia Group A to receive propofol 2mg/kg alone 20mins Induction of anaesthesia 40
Experimental Group Induction of Anaesthesia group B to receive propofol-ketamine 2mg/kg- 0,5mg/kg 20 mins Induction of anaesthesia 40
Experimental Group Induction of anaesthesia group C to receive propofol- ketamine 2mg/kg- 0,75mg/kg 20 mins Induction of anaesthesia 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
male and female patients aged between 18 and 50 years who are scheduled to undergo an elective general anaesthetic at Parirenyatwa and Harare Central Hospitals Patients will be recruited from general surgery, urology, gynecology and orthpeadic lists ASA grade greater than III Pregnant women Hypertensive patients Patients with a history of drug or alcohol abuse Patients on medications that directly affect the CVS and neurological systems Patients with psychiatric diseases 18 Year(s) 50 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 MCAZ
Ethics Committee Address
Street address City Postal code Country
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. To evaluate if ketofol has better a haemodynamic profile as an induction agent than propofol alone Blood pressure and pulse will be measured every minute for the first 20 minutes after induction of anaesthesia
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Parirenyatwa Group of Hospitals Mazowe Street Harare 0000 Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
NECTAR Mazoe Street Harare 0000 Zimbabwe
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NECTAR Mozoe Street Harare 0000 Zimbabwe Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Dr S Shumbairerwa Department of Anaesthetics and Critical Care Medicine Harare 0000 Zimbabwe
Dr F Madzimbamuto Department of Anaesthetics and Critical Care Medicine Harare 0000 Zimbabwe
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Petros Manyumwa pmanyumwa@yahoo.com +263 77506388 Department of Anaesthetics and Critical Care Medicine, Mazoe Street, Belgravia
City Postal code Country Position/Affiliation
Harare 0000 Zimbabwe Jnr Registrar
Role Name Email Phone Street address
Public Enquiries Petros N Manyumwa pmanyumwa@yahoo.com +263 77506388 Department of Anaesthetics and Critical Care Medicine, Mazoe Street, Belgravia
City Postal code Country Position/Affiliation
Harare Zimbabwe Jnr Registrar
Role Name Email Phone Street address
Scientific Enquiries Petros N Manyumwa pmanyumwa@yahoo.com +263 77506388 Department of Anaesthetics and Critical Care Medicine, Mazoe Street, Belgravia
City Postal code Country Position/Affiliation
Harare Zimbabwe Jnr Registrar
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