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.: PACTR201905860970816 Date of Approval: 13/05/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Sedation during liposuction
Official scientific title Prospective study of sedation with propofol alone versus with dexameditomedine in outpatient tumescent liposuction
Brief summary describing the background and objectives of the trial Check availability of discharge after using propofol or propofol with dexameditomedine in outpatient liposuction
Type of trial RCT
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 10/03/2019
Actual trial start date 19/02/2019
Anticipated date of last follow up 07/03/2019
Actual Last follow-up date 20/08/2019
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Propfol group for sedation during tumescent liposuction Continous Infusion of 0. l-0 .5mg /kg in first 3 to 4 minutes and titrated to desired effect then 0.1-0.3 /kg/min Throughout the operation Continous infusion of propfol will start 5 min. Before the procedure 60 Uncontrolled
Experimental Group Proposal with dexameditomedine Continously infusion 0.1-0.5mg through first 5 minutes and titrated to effect then continue infusion 0.1-0.3 /kg/min Dexameditomedine 0.5mg/kg/hr Continous infusion Both drug infusion will start five min.before procedure 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I, II Age 18-50y.o BMI <35 KG/M2No or minor systemic disease Allergy to any drug used , Sever cardiopulmonary disease, sever coagulopathy, Patient Nedd or converted to GA High BMI>35kg/m2 Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 Year(s) Female
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 05/03/2019 Elmenoufia ethical comitte
Ethics Committee Address
Street address City Postal code Country
25 yassin abdelghafar Shibin alkom 2666 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Readness and time to discharge home Measure sedation score 5 , 10, 20,30 min and 1 hour after stop infusion.
Secondary Outcome Hemodynamic changes blood pressure, heart rate , temp, respiratory rate Base line and at 5 , 10 , 15 , 30 min and every 30 min after throughout procedure
Secondary Outcome Side effects respiratory depression, movement with surgical stimulation, hypotension , desaturation , braycardia, sedation score On 5 , 15, 30, 60, 90, 120 min
Secondary Outcome Amnesia and pt satisfaction 30 , 60 min after stop of infusion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia university 25- Yasin abd elghafar Shibin elkom 002048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hanaa abouelfetouh elfeky 25-yassin abdelghafar Shibin elkom 002048 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine 25-yasin abdelghafar Shibin elkom 002048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Nadia mohie eldine Shibin elkom Shibin elkom 002048 Egypt
Hazem elsersy 2525-yassin abdelghafar Shibin elkom 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hanaa Elfeky hanaafotoh@yahoo.com 00971508987298 25 Yassin abd elghafar
City Postal code Country Position/Affiliation
Shibin alkom Egypt Lecturer of anesthesia and icu
Role Name Email Phone Street address
Public Enquiries Hazem Elsersy hazelsersy@Hotmail.com 00201091096655 25 Yassin abdelghafar
City Postal code Country Position/Affiliation
Shibin alkom Egypt Assistant professor anesthesia and icu
Role Name Email Phone Street address
Scientific Enquiries Nadia Bahgat dr_nmbahgat@yahoo.com 0020122850598 25 yassin abd elghafar
City Postal code Country Position/Affiliation
Shibin alkom Egypt Lecturer of anesthesia and icu
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Demographic data, baseline and subsequent heart rate ,blood pressure ,temp,saturation ,respiratory rate, sedation score, movement during procedure, recall , recovery time ,discharge time , and pt satisfaction. Informed Consent Form,Statistical Analysis Plan,Study Protocol First of March 2020 Propofol, deximeditomedine, adrenaline lidocaine and tumescent liposuction
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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