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

Sponsor
Alexandria University (Other)
Overall Status
Completed
CT.gov ID
NCT05636566
Collaborator
(none)
60
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3
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7.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Sixty patients were randomized and assigned into 3 groups (n=20) each, using sealed envelope technique: Group (S): received sevoflurane- oxygen for induction and sevoflurane with fentanyl (Fentanyl, Janssen-Cilag, Germany) infusion for maintenance of anaesthesia. Group (P): received propofol (Diprivan, Astra Zeneca, Wedel, Germany) for induction followed by propofol-fentanyl infusions for maintenance of anaesthesia. Group (D): received dexmedetomedine (Precedex, Dexmedetomedine HCL inj.,Hospira, Inc.,Lacke Forest, USA) infusion for induction followed by dexmedetomedine-fentanyl infusions for maintenance of anaesthesia. All solutions were prepared by a team member not participating in data recording of the study.Sixty patients were randomized and assigned into 3 groups (n=20) each, using sealed envelope technique:Group (S): received sevoflurane- oxygen for induction and sevoflurane with fentanyl (Fentanyl, Janssen-Cilag, Germany) infusion for maintenance of anaesthesia. Group (P): received propofol (Diprivan, Astra Zeneca, Wedel, Germany) for induction followed by propofol-fentanyl infusions for maintenance of anaesthesia. Group (D): received dexmedetomedine (Precedex, Dexmedetomedine HCL inj.,Hospira, Inc.,Lacke Forest, USA) infusion for induction followed by dexmedetomedine-fentanyl infusions for maintenance of anaesthesia. All solutions were prepared by a team member not participating in data recording of the study.
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Comparison Between TIVA Using Propofol or Dexmedetomidine Versus Sevoflurane During Anaesthesia of Children Undergoing Bone-Marrow Aspiration
Actual Study Start Date :
Feb 15, 2022
Actual Primary Completion Date :
Sep 15, 2022
Actual Study Completion Date :
Oct 25, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. sedation score [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.

Secondary Outcome Measures

  1. time for spontenous eye opening [immediately postoperative]

    assessement of the immediate time of recovery

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alexandria University Faculty of Medicin Alexandria Egypt 21615

Sponsors and Collaborators

  • Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alexandria University
ClinicalTrials.gov Identifier:
NCT05636566
Other Study ID Numbers:
  • 0305414
First Posted:
Dec 5, 2022
Last Update Posted:
Dec 5, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alexandria University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 5, 2022