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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201609001759210 |
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Date of registration:
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01/09/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparative study of intravenous ketamine and tramadol for the prevention of shivering in parturients undergoing cesarean section under spinal anesthe
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Scientific title:
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Efficacy intravenous tramadol and low dose ketamine in the prevention of post spinal anaesthesia shivering following cesarean section |
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Date of first enrolment:
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05/09/2016 |
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Target sample size:
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123 |
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Recruitment status: |
Complete |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1759 |
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Study type:
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Interventional |
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Study design:
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Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously,Randomised,simple randomisation using lotery methods ,Numbered containers
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Phase:
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Not Applicable
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Countries of recruitment
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Ethiopia
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Contacts
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Name:
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Yilkal
Tadesse |
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Address:
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Azezo
196
Gondar
Ethiopia |
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Telephone:
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+251-9-18-72-78-06 |
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Email:
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yilkaltadesse@yahoo.com |
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Affiliation:
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University of Gondar |
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Name:
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Amare
hailekiros |
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Address:
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Azezo
196
Gondar
Ethiopia |
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Telephone:
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+251-9-63-73-42-43 |
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Email:
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amaretom22@gmail.com |
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Affiliation:
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University of Gondar |
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Key inclusion & exclusion criteria
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Inclusion criteria: 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.
Exclusion criteria: 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.
Age minimum:
18 Year(s)
Age maximum:
39 Year(s)
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Anaesthesia
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cesarean section
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Pregnancy and Childbirth
Surgery
cesarean section
Anaesthesia
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Surgery
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Pregnancy and Childbirth
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Intervention(s)
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normal saline
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tramadol group
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ketamine group
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Primary Outcome(s)
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reducing the incidence(%) of shivering following cesarean section under spinal anesthesia
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Secondary Outcome(s)
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unwanted effects of the prophylaxis
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Source(s) of Monetary Support
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University of gondar
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Ethics review
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Status: Approved
Approval date: 25/08/2016
Contact:
Hailu yimer
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Status: Approved
Approval date: 29/08/2016
Contact:
Alemayehu desalegn
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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