RecruitingPhase 4NCT04475705

Propofol vs Sevo for Paediatric Tumor Surgery

The Effects of Propofol Based Intravenous vs Sevoflurane Inhalation Anaesthesia on Inflammation and Circulating Tumor Cells in Paediatric Tumor Surgery - a Pilot Study


Sponsor

Hong Kong Children's Hospital

Enrollment

100 participants

Start Date

Jan 11, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 6 MonthsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called propofol and a drug called sevoflurane for people with cancer, carcinoma, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGpropofol

intravenous propofol using Target Controlled Infusion 'Paedfusor' model 2-5 as the main anaesthetic to achieve Bispectral Index 40-60

DRUGsevoflurane

sevoflurane at Minimal Alveolar Concentration 0.7-1.3 as the main anaesthetic to achieve Bispectral Index 40-60.


Locations(1)

Hong Kong Children's Hospital

Hong Kong, Hong Kong

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NCT04475705


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