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Controlled randomized double blind study: Comparison of Dexmedetomidine versus Propofol for Maintenance of Anesthesia during invasive procedures In Pediatric Oncology Patients

Controlled randomized double blind study:Comparison of Dexmedetomidine versus Propofol for Maintenance of Anesthesia during invasive procedures In Pediatric Oncology Patients.

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000149763
Enrollment
40
Registered
2013-02-07
Start date
2013-05-17
Completion date
2013-06-14
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 .

Interventions

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 bo

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.

Sponsors

Ahmad ramzy
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026