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

NCT05636566 | Completed Phase 2 DMC

• 1 other identifier: 0305414
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Invasive Cancer; Pediatric Cancer

Keywords

Dex-Profol; sevoflurane

Outcome Measures

Primary Outcomes (1)

• sedation score

  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 Outcomes (1)

• time for spontenous eye opening

  immediately postoperative

Study Arms (3)

Group (S)

ACTIVE COMPARATOR

sevoflurane inhalational anaesthesia for induction, then sevoflurane and fentanyl infusion for maintenance ,

Drug: Sevoflurane

Group P

ACTIVE COMPARATOR

propofol infusion for induction afterward propofol and fentanyl infusions for maintenance of anaesthesia

Drug: Propofol infusion for maintance

Group D

ACTIVE COMPARATOR

dexmedetomedine infusion for induction after that dexmedetomedine and fentanyl infusions for maintenance

Drug: Dexmedetomidine

Interventions

Sevoflurane DRUG

inhalational anaesthesia for maintenance

Group (S)

Propofol infusion for maintance DRUG

propofol infusion after induction for maintenance of anaesthesia

Group P

Dexmedetomidine DRUG

0.5 mic /kg dexmedetomedine is injected after induction of anaesthesia

Group D

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University Faculty of Medicin

Alexandria, 21615, Egypt

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Sevoflurane; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: December 5, 2022
• Study Start: February 15, 2022
• Primary Completion: September 15, 2022
• Study Completion: October 25, 2022
• Last Updated: December 5, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)