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.: PACTR201710002706318 Date of Approval: 18/10/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative Study Between Dexmedetomidine and Ondansteron for Prevention of Post Spinal Shivering
Official scientific title Comparative Study Between Dexmedetomidine and Ondansteron for Prevention of Post Spinal Shivering
Brief summary describing the background and objectives of the trial Background & Objective: Both general and regional anesthesia are known to affect the efficiency of the homeostatic system and may result in different degrees of perioperative hypothermia. Perioperative hypothermia and shivering is one of the frequent, undesirable and unpleasant complications of both general and regional anesthesia. We conducted our study to evaluate and compare the relative efficacy and safety of dexmedetomidine and ondansetron for prevention of shivering during spinal anesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases,post spinal shivering
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/06/2017
Actual trial start date 01/06/2017
Anticipated date of last follow up 31/10/2017
Actual Last follow-up date 31/10/2017
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 120
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
not yet
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 Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program 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 Dexmedetomidine (1¿g/kg) iv once iv postoperative 40
Experimental Group Dexmedetomidine (1¿g/kg) iv , once the day of the operation , immediately postoperative iv single, drud 40
Experimental Group ondansetron drug 8 mg iv,once intraoperative drug iv, prevention of shivering 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
120 patients of both genders aged 18-60 years ASA physical status I&II, undergoing elective surgical procedures in the lower half of the body (orthopedic, general or gynaecological surgeries) were included. Surgical procedures included hernioplasty, appendicectomy, vaginal hysterectomy, abdominal hysterectomy or open reduction and fixation of lower limbs. Patients excluded from our study were those with thyroid disorders, patients with a history of convulsions, multiple allergies, severe cardiopulmonary diseases, pregnancy, uncooperative patients, patients requiring blood transfusion and patients with severe hepatic or renal diseases 18 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 15/10/2017 Faculty of Medicine Ethical Committe
Ethics Committee Address
Street address City Postal code Country
Fayoum University , District Fayoum 63514 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome shivering score 5,10,15,20,25,30,35,40,45 minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fayoum university Hospitals, Faculty of Medicine , Fayoum University Fayoum University District Fayoum 63514 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no funding source
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of Medicine Fayoum University Fayoum University District Fayoum 63514 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Joseph Makram Botros 105 Toman Bai Street Cairo 11321 Egypt
Atef Mohamed Sayed Khalil Fayoum University District Fayoum 63514 Egypt
Safaa Gaber Ragag University District fayoum 63514 Egypt
Mohammad Awad ElSayed Ahmed University District Fauyoum 63514 Egypt
Hany Maher Roushdy Salib Ain Shams University Hospitals Cairo 11588 Ecuador
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Atef Mohamed Sayed Khalil dr.atef.khalil@gmail.com 0201016581609 Fayoum University Hospitals
City Postal code Country Position/Affiliation
Fayoum 63514 Egypt Lecturer of Anesthesiology , Faculty of Medicine Fayoum University
Role Name Email Phone Street address
Principal Investigator Mohamed Awad ElSayed Ahmed drm.awad2008@yahoo.com 02 01223881100 Fayoum District
City Postal code Country Position/Affiliation
Fayoum 63514 Egypt Lecturer of Anesthesiology Fayoum University
Role Name Email Phone Street address
Public Enquiries Joseph Makram Botros dr_jo27@yahoo.com 02 01227598825 105 Toman Bai St, Zeitoun , Cairo
City Postal code Country Position/Affiliation
Cairo 11321 Egypt Lecturer of Anesthesiology, Fayoum Faculty of Medicine, Fayoum University
REPORTING
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