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Trial registered on ANZCTR


Registration number
ACTRN12613000149763
Ethics application status
Approved
Date submitted
4/02/2013
Date registered
7/02/2013
Date last updated
13/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Controlled randomized double blind study: Comparison of Dexmedetomidine versus Propofol for Maintenance of Anesthesia during invasive procedures In Pediatric Oncology Patients
Scientific title
Controlled randomized double blind study:Comparison of Dexmedetomidine versus Propofol for Maintenance of Anesthesia during invasive procedures In Pediatric Oncology Patients.
Secondary ID [1] 281866 0
nill
Universal Trial Number (UTN)
U1111-1139-0113
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pediatric oncology 288246 0
Condition category
Condition code
Anaesthesiology 288600 288600 0 0
Anaesthetics
Cancer 288601 288601 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
40 children, were randomized to receive either Propofol infusion started at a rate of 2mg/kg over 10 min then the infusion rate of 50 ug/kg/min were adjusted until patient fall a sleep and reach a sedation score 5-6 according to Ramsay sedation score .Or to receive Dexmedetomidine infusion started at a rate of 0.5ug/kg intravenously for 10 min , Then a continous infusion of 0.5ug/kg/hr was adjusted until patient fall asleep and the sedation score became 5-6 and be able to be positioned.

In both groups,Immediately before the procedure 0.5 mg/kg Ketamine was administered intravenously,Then Incremental doses of Ketamine 0.3mg/kg was administered intravenously to maintain sedation score 5-6 intraoperatively.
Intervention code [1] 286428 0
Treatment: Drugs
Comparator / control treatment
Dexmedetomidine infusion started at a rate of 0.5ug/kg intravenously for 10 min , Then a continous infusion of 0.5ug/kg/hr was adjusted until patient fall asleep and the sedation score became 5-6 and be able to be positioned.Immediately before the procedure 0.5 mg/kg Ketamine was administered intravenouslyand then Incremental doses of Ketamine 0.3mg/kg was administered intravenously to maintain sedation score 5-6
Control group
Active

Outcomes
Primary outcome [1] 288750 0
Frequency and total dose of ketamine used to keep the intraoperative sedation score of 5-6 Using Ramsay Sedation Score
Timepoint [1] 288750 0
intraoperative
Primary outcome [2] 288751 0
post operative recovery profile
Recovery excitement score developed by Kegan will be used by the observer to assess degree of agitation upon emerge from sedation (1 -(none)awake and calm, cooperative; 2 –(mild) crying occasionally; 3 –(moderate) irritable/restless, screaming,inconsolable; 4 –(marked) combative, disoriented,thrashing).
Timepoint [2] 288751 0
immediately postoperative ( at the end of the procedure)
Secondary outcome [1] 300905 0
hemodynamic stability (Heart rate, oxygen saturation, blood pressure)
will be recorded intraoperatively in consecutive 5-min intervals in both groups using( Patex, Ohmeda S/5Avance) standard monitor.
Timepoint [1] 300905 0
intraoperative

Eligibility
Key inclusion criteria
Children between 6-12years. diagnosed as either acute lymphocytic leukemia or acute myeloid leukemia with ASA physical status I–II scheduled for for diagnostic or prognostic lumbar puncture or bone marrow biopsy. will be eligible for inclusion in the study.
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
ASA physical status III–IV, age less than6 years or more than 12 years,congenital heart disease, cardiomyopathy, any rhythm other than sinus rhythm, liver or renal disease, upper respiratory infection, behavioral problems, patient on anticoagulant, beta blocker, clonidine, or digoxin.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Children between 6-12years. diagnosed as either acute lymphocytic leukemia or acute myeloid leukemia with ASA physical status I–II scheduled for for diagnostic or prognostic lumbar puncture or bone marrow biopsy. will be recruited.

Patients with ASA physical status III–IV, age less than6 years or more than 12 years,congenital heart disease, cardiomyopathy, any rhythm other than sinus rhythm, liver or renal disease, upper respiratory infection, behavioral problems, patient on anticoagulant, beta blocker, clonidine, or digoxin will be excluded.

Patients will be randomly allocated using computer generated
numbers. Allocation will beconcealed using
opaque sealed envelopes that will be opened just prior
to induction of general anaesthesia.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomization will be done using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data will be statistically described in terms of mean +-standard deviation , or frequencies (number of cases) and percentages when appropriate. Data will be tested for normality using Kolmogorov Smirnov test. Comparison between the two study groups will bedone using Student t test for independent samples. p values less than 0.05 will be considered statistically significant. All statistical calculations will be done using computer programs SPSS (Statistical Package for the Social Science; SPSS Inc., Chicago, IL, USA) version 15 for Microsoft Windows

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/05/2013
Actual
Date of last participant enrolment
Anticipated
14/06/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 4827 0
Egypt
State/province [1] 4827 0
cairo

Funding & Sponsors
Funding source category [1] 286643 0
Self funded/Unfunded
Name [1] 286643 0
Country [1] 286643 0
Egypt
Primary sponsor type
Individual
Name
Ahmad ramzy
Address
King Faisal Specialist Hospital and research center,Anesthesia department,MBC J22
Rawda street, pobox 40047.Jeddah 21499, Saudi Arabia.
Country
Saudi Arabia
Secondary sponsor category [1] 285426 0
None
Name [1] 285426 0
Address [1] 285426 0
Country [1] 285426 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288748 0
Ain Shams university, Faculty of medicine
Ethics committee address [1] 288748 0
pobox 11566, Abbasya Square 11566, Cairo, Egypt
Ethics committee country [1] 288748 0
Egypt
Date submitted for ethics approval [1] 288748 0
04/02/2013
Approval date [1] 288748 0
08/05/2013
Ethics approval number [1] 288748 0

Summary
Brief summary
Context:
Dexmeditomedine infusion in oncology pediatric patients is used to perform repeated lumbar puncture and bone marrow aspiration.

Objective:

We hypothesized that dexmetomedine could be effectively used as a sedative/analgesic agent for children requiring the above procedures,We designed our study to compare the effects of dexmedetomidine infusion versus propofol infusion on perioperative hemodynamics, sedation, pain, and recovery scores for invasive procedures in pediatric oncology patients.

Design: Randomised double blind study

Patients or other participant:
Forty ASA 1 or 2 children, 6–12 yearsr of age, with hematological cancer , were randomized to receive either propofol infusion ( Group A)or dexmedetomidine infusion (Group B) during anesthesia for diagnostic or prognostic short duration procedures .

Intervention(s) :
Patients were assigned to receive either Propofol infusion started at a rate of 2mg/kg over 10 min then the infusion rate of 50 ug/kg/min were adjusted until patient fall a sleep and reach a sedation score 5-6 according to Ramsay sedation score Or to receive , Dexmedetomidine infusion started at a rate of 0.5ug/kg intravenously for 10 min, Then a continous infusion of 0.5ug/kg/hr was adjusted until patient fall asleep and the sedation score became 5-6 and be able to be positioned. In both Groups, Immediately before the procedure 0.5 mg/kg Ketamine was administered intravenously .
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37466 0
Dr Ahmad Ramzy Shaaban
Address 37466 0
King Faisal Specialist Hospital and research center,Anesthesia department,MBC J22
Rawda street, pobox 40047.Jeddah 21499, Saudi Arabia. ,
Country 37466 0
Saudi Arabia
Phone 37466 0
+966534409797
Fax 37466 0
Email 37466 0
[email protected]
Contact person for public queries
Name 37467 0
Dr Ahmad Ramzy
Address 37467 0
King Faisal Specialist Hospital and research center,Anesthesia department,MBC J22
Rawda street, pobox 40047.Jeddah 21499, Saudi Arabia
Country 37467 0
Saudi Arabia
Phone 37467 0
+966534409797
Fax 37467 0
Email 37467 0
[email protected]
Contact person for scientific queries
Name 37468 0
Dr Ahmad Ramzy
Address 37468 0
King Faisal Specialist Hospital and research center,Anesthesia department,MBC J22
Rawda street, pobox 40047.Jeddah 21499, Saudi Arabia
Country 37468 0
Saudi Arabia
Phone 37468 0
+966534409797
Fax 37468 0
Email 37468 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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