Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Hong Kong Children's Hospital
Hong Kong, Hong Kong
Actively Recruiting
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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