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Comparing TIVA Using Propofol or Dexmedetomidine Versus Sevoflurane During Anaesthesia of Children Undergoing Bone-Marrow Aspiration

NCT05636566 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-12-05

No results posted yet for this study

Summary

No doubt that children facing surgical procedures are subjected to perioperative distressing, anxious and worrying periods. Several factors included; parental deprivation, anxiety, previously mismanaged experience and anticipating pain from the procedure itself weather diagnostic or curative. Anaesthetic goals should focus at alleviating these unfavorable events that may exacerbate the inevitable associated neurohormal stress response with its injurious effects on the course of the procedure. Moreover, it likely to extend beyond the surgical procedure predisposing these vulnerable group of patients to psychological trauma and chronic behavioral changes.

Bone marrow aspiration (BMA) is a frequent procedure that necessitate a meticulous anaesthetic plane that entails rapid non-traumatic induction together with adequate pain free maintenance and instant smooth recovery after a short time practice. Total intravenous anaesthesia (TIVA) had emerged as alternative anaesthetic technique to inhalational anaesthesia for conscious sedation in BMA cited by many authors.

Propofol a popular anaesthetic/ sedative with a rapid onset, short duration and smooth recovery of consciousness and psychomotor functions with no cumulation. However it is poorly analgesic, depresses respiration and there is a possibility of loss of muscle tone leading to airway obstruction .

Dexmedetomidine is a greatly active α2 adrenergic agonist with a valuable anaesthetic- analgesic saving effects. It augments sedation, hypnosis and preservation of muscle tone with negligible respiratory depression and hemodynamic derangements.

The purpose of the current study is to compare between effects of TIVA using propofol or dexmedetomedine versus sevoflurane for maintenance of anaesthesia in children undergoing bone marrow aspiration.

Conditions

  • Invasive Cancer
  • Pediatric Cancer

Interventions

DRUG

Sevoflurane

inhalational anaesthesia for maintenance

DRUG

Propofol infusion for maintance

propofol infusion after induction for maintenance of anaesthesia

DRUG

Dexmedetomidine

0.5 mic /kg dexmedetomedine is injected after induction of anaesthesia

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-15
Primary Completion
2022-09-15
Completion
2022-10-25

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05636566 on ClinicalTrials.gov