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

December 1, 2022 updated by: Alexandria University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: although bone marrow aspiration in children is a familiar short duration procedure, nearly 65% of patients develop sever anxiety that may extend more beyond, up to chronic postoperative behavioral changes. Consequently, the objectives of any related anaesthetic technique is to afford smooth non-traumatic induction with safe maintenance and rapid recovery. The rational of the present study is to compare between TIVA using propofol or dexmedetomedine and sevoflurane for maintenance of anaesthesia in children scheduled for bone marrow aspiration.

Patients and methods: 60 child aged 3-12 years with ASA physical status I and II planned for elective bone marrow biopsy and aspiration were enrolled randomly into 3 groups 20 child each; group(S): received sevoflurane- oxygen for induction and sevoflurane with fentanyl infusion for maintenance of anaesthesia. Group (P): received propofol for induction followed by propofol-fentanyl infusions for maintenance of anaesthesia. Group (D): received dexmedetomedine infusion for induction followed by dexmedetomedine-fentanyl infusions for maintenance of anaesthesia. The primary endpoint was postoperative sedation score on arrival to the post anaesthetic care unit (PACU) after surgery. Secondary outcomes included procedure duration, hemodynamic variables, parents and surgeons satisfaction and incidences of any adverse events.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21615
        • Alexandria University Faculty of Medicin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients aged 3-12 years.
  • both sexes
  • ASA physical status I and II

Exclusion Criteria:

  • Patients with identified allergy to the study medications
  • with recognized lipid or carbohydrate deranged metabolism
  • cardiac dysrhythmias
  • congenital heart diseases
  • cardiomyopathy
  • significant organ dysfunction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group (S)
sevoflurane inhalational anaesthesia for induction, then sevoflurane and fentanyl infusion for maintenance ,
Drug: Sevoflurane
inhalational anaesthesia for maintenance
Active Comparator: Group P
propofol infusion for induction afterward propofol and fentanyl infusions for maintenance of anaesthesia
Drug: Propofol infusion for maintance
propofol infusion after induction for maintenance of anaesthesia
Active Comparator: Group D
dexmedetomedine infusion for induction after that dexmedetomedine and fentanyl infusions for maintenance
Drug: Dexmedetomidine
0.5 mic /kg dexmedetomedine is injected after induction of anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sedation score
Time Frame: immediately postoperative
indicator for post operative alertness, . Sedation level: Agitated = 4, Awake= 3, Drowsy= 2, Asleep= 1. A sedation score of 3 & above was considered as unsatisfactory while 1 & 2 is considered to be satisfactory.
immediately postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time for spontenous eye opening
Time Frame: immediately postoperative
assessement of the immediate time of recovery
immediately postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2022

Primary Completion (Actual)

September 15, 2022

Study Completion (Actual)

October 25, 2022

Study Registration Dates

First Submitted

November 18, 2022

First Submitted That Met QC Criteria

December 1, 2022

First Posted (Actual)

December 5, 2022

Study Record Updates

Last Update Posted (Actual)

December 5, 2022

Last Update Submitted That Met QC Criteria

December 1, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0305414

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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