Propofol vs Sevo for Paediatric Tumor Surgery

March 14, 2022 updated by: Hong Kong Children's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Surgical resection is the main modality of treatment for many solid tumors. Despite successful tumor resection, some patients develop local recurrence or metastasis, causing morbidities and mortality. In recent years, there is growing interest in the pathophysiology of recurrence or metastasis. It is believed that the recurrence is caused by the liberation of circulating tumor cells during surgical manipulation of the tumors and the vascular invasive properties of the tumor cells. Perioperative events, such as surgical stress and anaesthesia may have immunomodulating effects, causing growth or inhibition of circulating tumor cells, which affect disease relapse. There is growing evidence that propofol is anti-inflammatory while sevoflurane is pro-inflammatory and their potential roles in cancer recurrence attract researchers' attention. In adults, there is increasing number of researches showing that propofol may improve patient outcomes in terms of disease survival, when compared to sevoflurane. However, such evidence in paediatric population is lacking. This study aims to compare the effects of propofol based intravenous anaesthesia with inhalation anaesthesia with sevoflurane on perioperative biomarkers of inflammation, circulating tumor cells and disease free survival in 3 years.

100 patients will be recruited for this single blinded randomised controlled trial. They will receive general anaesthesia in Hong Kong Children's Hospital for their primary tumor excision surgery. 50 patients will be randomised to sevoflurane group and 50 patients will be randomised to propofol group. They will receive standardised anaesthetic management in terms of death or anaesthesia, pain management, fluid or thermoregulation management. Sevoflurane group subjects will receive inhalational sevoflurane as main anaesthetic, while propofol group subjects will receive intravenous propofol. These patients will have 4 blood tests collected for analysis for biomarkers of inflammation, DNA damage, oxidative stress and circulating tumor cells.

  • baseline: once patients have intravenous access established
  • intraoperative: when the tumor is deemed resected by surgeons
  • immediately postop: after wound closure
  • 24 hours postop Early postoperative period follow up will look for wound recovery, sepsis, and time to start chemotherapy and need for second look operation for wound complication.

Patients will also followed up for 3 years for tumor recurrence and disease survival.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Hong Kong Children's Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients coming for elective primary solid tumor resection for curative intent in Hong Kong Children's Hospital
  • AND patients > 5kg
  • AND patients within age limit

Exclusion Criteria:

  • Autoimmune / Chronic inflammatory diseases e.g. Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA) etc.
  • Current Steroid therapy
  • Surgery for tumour removal in the past year
  • Allergy to Propofol
  • intraoperative use of nitrous oxide
  • Patient susceptible to Malignant Hyperthermia
  • Patients / parents / legal guardians showing preference in anaesthetic techniques during recruitment process

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sevoflurane group
patients in this group will receive inhalation anaesthesia with sevoflurane at Minimal Alveolar Concentration 0.7-1.3 as the main anaesthetic to achieve Bispectral Index 40-60. Other anaesthetic management will be standardised.
Drug: sevoflurane
sevoflurane at Minimal Alveolar Concentration 0.7-1.3 as the main anaesthetic to achieve Bispectral Index 40-60.
Other Names:
  • ultane, sevorane
Active Comparator: propofol group
patients in this group will receive intravenous propofol using Target Controlled Infusion 'Paedfusor' model 2-5 as the main anaesthetic to achieve Bispectral Index 40-60. Other anaesthetic management will be standardised.
Drug: propofol
intravenous propofol using Target Controlled Infusion 'Paedfusor' model 2-5 as the main anaesthetic to achieve Bispectral Index 40-60
Other Names:
  • Diprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference in Hypoxia Inducible Factor-1 gene expression
Time Frame: intraoperative to postoperative 24 hours
pg/mL
intraoperative to postoperative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference in levels of Interleukin-6
Time Frame: intraoperative to postoperative 24 hours
pg/mL
intraoperative to postoperative 24 hours
difference in levels of Tumor Necrosis Factor-alpha
Time Frame: intraoperative to postoperative 24 hours
pg/mL
intraoperative to postoperative 24 hours
difference in levels of high sensitivity C reaction protein
Time Frame: intraoperative to postoperative 24 hours
mg/L
intraoperative to postoperative 24 hours
difference in levels of DNA damage (Comet Assay)
Time Frame: intraoperative to postoperative 24 hours
%T (percent tail)
intraoperative to postoperative 24 hours
difference in levels of Glutathione Peroxidase
Time Frame: intraoperative to postoperative 24 hours
μg/mL
intraoperative to postoperative 24 hours
difference in levels of Superoxide dismutase
Time Frame: intraoperative to postoperative 24 hours
units/ml
intraoperative to postoperative 24 hours
difference in levels of urinary 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-oxodG)
Time Frame: intraoperative to postoperative 24 hours
ng/mL
intraoperative to postoperative 24 hours
difference in levels of 8-oxo-7,8-dihydroguanosine (8-oxoGuo)
Time Frame: intraoperative to postoperative 24 hours
ng/mL
intraoperative to postoperative 24 hours
difference in the quantity of circulating tumor cells (CTC)
Time Frame: intraoperative to postoperative 24 hours
cells/100 µL
intraoperative to postoperative 24 hours
cancer free survival at 1 and 3 years
Time Frame: intraoperative to postoperative 24 hours
percent
intraoperative to postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hong Kong Children's Hospital

Collaborators

The University of Hong Kong

Investigators

  • Principal Investigator: Sau Man Lee, MBBS, Hong Kong Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2021

Primary Completion (Anticipated)

July 1, 2028

Study Completion (Anticipated)

July 1, 2028

Study Registration Dates

First Submitted

July 7, 2020

First Submitted That Met QC Criteria

July 14, 2020

First Posted (Actual)

July 17, 2020

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKCH-REC-2020-013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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