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.: PACTR201609001759210 Date of Approval: 01/09/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative study of intravenous ketamine and tramadol for the prevention of shivering in parturients undergoing cesarean section under spinal anesthe
Official scientific title Efficacy intravenous tramadol and low dose ketamine in the prevention of post spinal anaesthesia shivering following cesarean section
Brief summary describing the background and objectives of the trial Introduction: Shivering is a frequent and undesirable complication of spinal anaesthesia. It is considered to be a physiological response to increase body core temperature in an attempt to raise the metabolic heat production. However, shivering can double or even triple oxygen consumption and carbon dioxide production. This phenomenon may triggers myocardial ischemia, causes arterial hypoxemia, increase intraocular and intracranial pressures, increases wound pain, delayed wound healing, and interfere with pulse rate, blood pressure and electrocardiogram (ECG) monitoring. Objective: To compare the efficacy of low dose IV ketamine (0.2mg/kg) with tramadol (0.5mg/kg) to prevent shivering in patients undergoing cesarean delivery under spinal anaesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,cesarean section,Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 05/09/2016
Actual trial start date 05/09/2016
Anticipated date of last follow up 30/11/2016
Actual Last follow-up date 30/11/2016
Anticipated target sample size (number of participants) 123
Actual target sample size (number of participants) 123
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
60/09/08 30/09/08
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 lotery methods Numbered containers Open-label(Masking Not Used)
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised simple randomisation using lotery methods Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ketamine group 0.2mg/kg iv 2 hour giving 0.2mg/kg iv ketamine after spinal anaesthesia for prevention of shivering 41
Experimental Group tramadol group 0.5mg/kg 2 hour giving 0.5mg/kg iv tramadol for prevention of shivering folowing spinal anaesthesia 41
Control Group normal saline 5ml 2 hour 5ml of normal saline 41 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Parturients with ASA I physical status who will undergoing cesarean section under spinal anesthesia. 2. Parturients ASA II physical status II who will undergo cesarean section under spinal anesthesia. 1. Patient refusal 2. Hyperthyroidism 3. Known allergic to opioids and ketamine 4. History of cardiopulmonary disease, hypertension 5. Psychotic patients patient diagnosed with antepartum hemorrhage, cord prolapse, fetal distress 6. Temperature >38oc or <36 oc 7. History of alcohol or substance abuse, 8. Those patients who needed blood transfusion during surgery or who received medications likely to alter thermoregulation (opoids) spinal anaesthesia with combination of intrathecal fentanyl. 9. Spinal anaesthesia with sedation like propofol, pethidine and ketamine, failed spinal converted to general anaesthesia. 18 Year(s) 39 Year(s) Male
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 25/08/2016 Hailu yimer
Ethics Committee Address
Street address City Postal code Country
Atse bekafa Gondar 196 Ethiopia
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 25/08/2016 Hailu yimer
Ethics Committee Address
Street address City Postal code Country
Atse bekafa Gondar 196 Ethiopia
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 29/08/2016 Alemayehu desalegn
Ethics Committee Address
Street address City Postal code Country
Atse bekafa Gondar 196 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome reducing the incidence(%) of shivering following cesarean section under spinal anesthesia the presence or absence of shivering will be observed by the data collectors after 15 minutes following the administration of drugs in each group
Secondary Outcome unwanted effects of the prophylaxis occurrence of hypotension,nausea and vomiting,sedation will be observed for 2 hours following the administration of drugs .
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
gondar university hospital Atse Bekafa Gondar 196 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
University of gondar Maraki Gondar 196 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of gondar Maraki Gondar 196 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
departement of anaesthesiology and critical care Atse Bekafa Gondar 196 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Girmay Lema tsagir.fitiwi@gmail.com +251-9-12-86-21-44 Atse Bekafa
City Postal code Country Position/Affiliation
Gondar 196 Ethiopia
Role Name Email Phone Street address
Public Enquiries Yilkal Tadesse yilkaltadesse@yahoo.com +251-9-18-72-78-06 Azezo
City Postal code Country Position/Affiliation
Gondar 196 Ethiopia University of Gondar
Role Name Email Phone Street address
Scientific Enquiries Amare hailekiros amaretom22@gmail.com +251-9-63-73-42-43 Azezo
City Postal code Country Position/Affiliation
Gondar 196 Ethiopia University of Gondar
REPORTING
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