Actively Recruiting

Phase 4
Age: 6Months - 18Years
All Genders
NCT04475705

Propofol vs Sevo for Paediatric Tumor Surgery

Led by Hong Kong Children's Hospital · Updated on 2022-03-16

100

Participants Needed

1

Research Sites

389 weeks

Total Duration

On this page

Sponsors

H

Hong Kong Children's Hospital

Lead Sponsor

T

The University of Hong Kong

Collaborating Sponsor

AI-Summary

What this Trial Is About

Background: Retrospective studies and meta-analyses have shown a reduction in 5-year survival following inhalational based compared to propofol based total intravenous (TIVA) anaesthesia for cancer surgery. To date there have been no prospective trials published which evaluate the effect of anaesthetic technique on circulating tumour cells (CTC), oxidative stress, and recurrence rate following cancer surgery. Children with cancer often require surgery for tumour excision as well as for other diagnostic and therapeutic procedures. To date there has been no prospective randomized controlled trial evaluating the optimal anaesthetic technique for surgery on children with cancer. Aim: This is a pilot study in paediatric patients who require surgery for tumour excision. The aim is to investigate the effect of sevoflurane inhalational versus propofol intravenous anaesthesia on expression of hypoxia-inducible factor 1 (HIF-1), circulating tumour cells, DNA damage and biomarkers of immunity and inflammation in patients before and after tumour surgery. The patients will be followed up for up to 5 years for tumour recurrence after surgery. Method: This will be a single-blinded randomized controlled trial. One hundred children undergoing tumour excision surgery at the Hong Kong Children's Hospital will be recruited and randomized to receive TIVA or inhalational anaesthesia. Baseline, intraoperative and postoperative blood will be taken for tests of immunity and inflammatory markers, DNA damage and circulating tumour cells. Patients would be followed up to 3 years for tumour recurrence and survival.

CONDITIONS

Official Title

Propofol vs Sevo for Paediatric Tumor Surgery

Who Can Participate

Age: 6Months - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled for elective primary solid tumor removal surgery for curative intent at Hong Kong Children's Hospital
  • Patients weighing more than 5 kilograms
  • Patients aged between 0.5 months and 18 years
Not Eligible

You will not qualify if you...

  • Autoimmune or chronic inflammatory diseases such as Systemic Lupus Erythematosus or Rheumatoid Arthritis
  • Current steroid therapy
  • Tumor removal surgery within the past year
  • Allergy to propofol
  • Intraoperative use of nitrous oxide
  • Susceptibility to Malignant Hyperthermia
  • Patients, parents, or legal guardians who prefer a specific anesthetic technique during recruitment

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hong Kong Children's Hospital

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

S

Sau Man Lee, MBBS

CONTACT

V

Vivian Yuen, MBBS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Propofol vs Sevo for Paediatric Tumor Surgery | DecenTrialz