<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04475705</url>
  </required_header>
  <id_info>
    <org_study_id>HKCH-REC-2020-013</org_study_id>
    <nct_id>NCT04475705</nct_id>
  </id_info>
  <brief_title>Propofol vs Sevo for Paediatric Tumor Surgery</brief_title>
  <official_title>The Effects of Propofol Based Intravenous vs Sevoflurane Inhalation Anaesthesia on Inflammation and Circulating Tumor Cells in Paediatric Tumor Surgery - a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hong Kong Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hong Kong Children's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Retrospective studies and meta-analyses have shown a reduction in 5-year survival following&#xD;
      inhalational based compared to propofol based total intravenous (TIVA) anaesthesia for cancer&#xD;
      surgery. To date there have been no prospective trials published which evaluate the effect of&#xD;
      anaesthetic technique on circulating tumour cells (CTC), oxidative stress, and recurrence&#xD;
      rate following cancer surgery. Children with cancer often require surgery for tumour excision&#xD;
      as well as for other diagnostic and therapeutic procedures. To date there has been no&#xD;
      prospective randomized controlled trial evaluating the optimal anaesthetic technique for&#xD;
      surgery on children with cancer.&#xD;
&#xD;
      Aim:&#xD;
&#xD;
      This is a pilot study in paediatric patients who require surgery for tumour excision. The aim&#xD;
      is to investigate the effect of sevoflurane inhalational versus propofol intravenous&#xD;
      anaesthesia on expression of hypoxia-inducible factor 1 (HIF-1), circulating tumour cells,&#xD;
      DNA damage and biomarkers of immunity and inflammation in patients before and after tumour&#xD;
      surgery. The patients will be followed up for up to 5 years for tumour recurrence after&#xD;
      surgery.&#xD;
&#xD;
      Method:&#xD;
&#xD;
      This will be a single-blinded randomized controlled trial. One hundred children undergoing&#xD;
      tumour excision surgery at the Hong Kong Children's Hospital will be recruited and randomized&#xD;
      to receive TIVA or inhalational anaesthesia. Baseline, intraoperative and postoperative blood&#xD;
      will be taken for tests of immunity and inflammatory markers, DNA damage and circulating&#xD;
      tumour cells. Patients would be followed up to 3 years for tumour recurrence and survival.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgical resection is the main modality of treatment for many solid tumors. Despite&#xD;
      successful tumor resection, some patients develop local recurrence or metastasis, causing&#xD;
      morbidities and mortality. In recent years, there is growing interest in the pathophysiology&#xD;
      of recurrence or metastasis. It is believed that the recurrence is caused by the liberation&#xD;
      of circulating tumor cells during surgical manipulation of the tumors and the vascular&#xD;
      invasive properties of the tumor cells. Perioperative events, such as surgical stress and&#xD;
      anaesthesia may have immunomodulating effects, causing growth or inhibition of circulating&#xD;
      tumor cells, which affect disease relapse. There is growing evidence that propofol is&#xD;
      anti-inflammatory while sevoflurane is pro-inflammatory and their potential roles in cancer&#xD;
      recurrence attract researchers' attention. In adults, there is increasing number of&#xD;
      researches showing that propofol may improve patient outcomes in terms of disease survival,&#xD;
      when compared to sevoflurane. However, such evidence in paediatric population is lacking.&#xD;
      This study aims to compare the effects of propofol based intravenous anaesthesia with&#xD;
      inhalation anaesthesia with sevoflurane on perioperative biomarkers of inflammation,&#xD;
      circulating tumor cells and disease free survival in 3 years.&#xD;
&#xD;
      100 patients will be recruited for this single blinded randomised controlled trial. They will&#xD;
      receive general anaesthesia in Hong Kong Children's Hospital for their primary tumor excision&#xD;
      surgery. 50 patients will be randomised to sevoflurane group and 50 patients will be&#xD;
      randomised to propofol group. They will receive standardised anaesthetic management in terms&#xD;
      of death or anaesthesia, pain management, fluid or thermoregulation management. Sevoflurane&#xD;
      group subjects will receive inhalational sevoflurane as main anaesthetic, while propofol&#xD;
      group subjects will receive intravenous propofol. These patients will have 4 blood tests&#xD;
      collected for analysis for biomarkers of inflammation, DNA damage, oxidative stress and&#xD;
      circulating tumor cells.&#xD;
&#xD;
        -  baseline: once patients have intravenous access established&#xD;
&#xD;
        -  intraoperative: when the tumor is deemed resected by surgeons&#xD;
&#xD;
        -  immediately postop: after wound closure&#xD;
&#xD;
        -  24 hours postop Early postoperative period follow up will look for wound recovery,&#xD;
           sepsis, and time to start chemotherapy and need for second look operation for wound&#xD;
           complication.&#xD;
&#xD;
      Patients will also followed up for 3 years for tumor recurrence and disease survival.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 11, 2021</start_date>
  <completion_date type="Anticipated">July 2028</completion_date>
  <primary_completion_date type="Anticipated">July 2028</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>single blind controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>difference in Hypoxia Inducible Factor-1 gene expression</measure>
    <time_frame>intraoperative to postoperative 24 hours</time_frame>
    <description>pg/mL</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>difference in levels of Interleukin-6</measure>
    <time_frame>intraoperative to postoperative 24 hours</time_frame>
    <description>pg/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>difference in levels of Tumor Necrosis Factor-alpha</measure>
    <time_frame>intraoperative to postoperative 24 hours</time_frame>
    <description>pg/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>difference in levels of high sensitivity C reaction protein</measure>
    <time_frame>intraoperative to postoperative 24 hours</time_frame>
    <description>mg/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>difference in levels of DNA damage (Comet Assay)</measure>
    <time_frame>intraoperative to postoperative 24 hours</time_frame>
    <description>%T (percent tail)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>difference in levels of Glutathione Peroxidase</measure>
    <time_frame>intraoperative to postoperative 24 hours</time_frame>
    <description>μg/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>difference in levels of Superoxide dismutase</measure>
    <time_frame>intraoperative to postoperative 24 hours</time_frame>
    <description>units/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>difference in levels of urinary 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-oxodG)</measure>
    <time_frame>intraoperative to postoperative 24 hours</time_frame>
    <description>ng/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>difference in levels of 8-oxo-7,8-dihydroguanosine (8-oxoGuo)</measure>
    <time_frame>intraoperative to postoperative 24 hours</time_frame>
    <description>ng/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>difference in the quantity of circulating tumor cells (CTC)</measure>
    <time_frame>intraoperative to postoperative 24 hours</time_frame>
    <description>cells/100 µL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cancer free survival at 1 and 3 years</measure>
    <time_frame>intraoperative to postoperative 24 hours</time_frame>
    <description>percent</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Solid Tumor</condition>
  <condition>Carcinoma</condition>
  <condition>Malignancy</condition>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Sevoflurane group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>propofol group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>propofol</intervention_name>
    <description>intravenous propofol using Target Controlled Infusion 'Paedfusor' model 2-5 as the main anaesthetic to achieve Bispectral Index 40-60</description>
    <arm_group_label>propofol group</arm_group_label>
    <other_name>Diprivan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sevoflurane</intervention_name>
    <description>sevoflurane at Minimal Alveolar Concentration 0.7-1.3 as the main anaesthetic to achieve Bispectral Index 40-60.</description>
    <arm_group_label>Sevoflurane group</arm_group_label>
    <other_name>ultane, sevorane</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients coming for elective primary solid tumor resection for curative intent in Hong&#xD;
             Kong Children's Hospital&#xD;
&#xD;
          -  AND patients &gt; 5kg&#xD;
&#xD;
          -  AND patients within age limit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Autoimmune / Chronic inflammatory diseases e.g. Systemic Lupus Erythematosus (SLE),&#xD;
             Rheumatoid Arthritis (RA) etc.&#xD;
&#xD;
          -  Current Steroid therapy&#xD;
&#xD;
          -  Surgery for tumour removal in the past year&#xD;
&#xD;
          -  Allergy to Propofol&#xD;
&#xD;
          -  intraoperative use of nitrous oxide&#xD;
&#xD;
          -  Patient susceptible to Malignant Hyperthermia&#xD;
&#xD;
          -  Patients / parents / legal guardians showing preference in anaesthetic techniques&#xD;
             during recruitment process&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sau Man Lee, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hong Kong Children's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sau Man Lee, MBBS</last_name>
    <phone>+85257413327</phone>
    <email>lsm335@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Vivian Yuen, MBBS</last_name>
    <phone>+85235133752</phone>
    <email>yuenmyv@ha.org.hk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hong Kong Children's Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rowena Lee</last_name>
      <phone>+85257413327</phone>
      <email>lsm335@ha.org.hk</email>
    </contact>
    <contact_backup>
      <last_name>Vivian Yuen</last_name>
      <phone>+85257413131</phone>
      <email>yuenmyv@ha.org.hk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <reference>
    <citation>Divatia JV, Ambulkar R. Anesthesia and cancer recurrence: What is the evidence? J Anaesthesiol Clin Pharmacol. 2014 Apr;30(2):147-50. doi: 10.4103/0970-9185.129990. No abstract available.</citation>
    <PMID>24803747</PMID>
  </reference>
  <reference>
    <citation>Heaney A, Buggy DJ. Can anaesthetic and analgesic techniques affect cancer recurrence or metastasis? Br J Anaesth. 2012 Dec;109 Suppl 1:i17-i28. doi: 10.1093/bja/aes421.</citation>
    <PMID>23242747</PMID>
  </reference>
  <reference>
    <citation>Vinay DS, Ryan EP, Pawelec G, Talib WH, Stagg J, Elkord E, Lichtor T, Decker WK, Whelan RL, Kumara HMCS, Signori E, Honoki K, Georgakilas AG, Amin A, Helferich WG, Boosani CS, Guha G, Ciriolo MR, Chen S, Mohammed SI, Azmi AS, Keith WN, Bilsland A, Bhakta D, Halicka D, Fujii H, Aquilano K, Ashraf SS, Nowsheen S, Yang X, Choi BK, Kwon BS. Immune evasion in cancer: Mechanistic basis and therapeutic strategies. Semin Cancer Biol. 2015 Dec;35 Suppl:S185-S198. doi: 10.1016/j.semcancer.2015.03.004. Epub 2015 Mar 25.</citation>
    <PMID>25818339</PMID>
  </reference>
  <reference>
    <citation>Demicheli R, Retsky MW, Hrushesky WJ, Baum M, Gukas ID. The effects of surgery on tumor growth: a century of investigations. Ann Oncol. 2008 Nov;19(11):1821-8. doi: 10.1093/annonc/mdn386. Epub 2008 Jun 10.</citation>
    <PMID>18550576</PMID>
  </reference>
  <reference>
    <citation>Tavare AN, Perry NJ, Benzonana LL, Takata M, Ma D. Cancer recurrence after surgery: direct and indirect effects of anesthetic agents. Int J Cancer. 2012 Mar 15;130(6):1237-50. doi: 10.1002/ijc.26448. Epub 2011 Nov 9.</citation>
    <PMID>21935924</PMID>
  </reference>
  <reference>
    <citation>Benzonana LL, Perry NJ, Watts HR, Yang B, Perry IA, Coombes C, Takata M, Ma D. Isoflurane, a commonly used volatile anesthetic, enhances renal cancer growth and malignant potential via the hypoxia-inducible factor cellular signaling pathway in vitro. Anesthesiology. 2013 Sep;119(3):593-605. doi: 10.1097/ALN.0b013e31829e47fd.</citation>
    <PMID>23774231</PMID>
  </reference>
  <reference>
    <citation>Kushida A, Inada T, Shingu K. Enhancement of antitumor immunity after propofol treatment in mice. Immunopharmacol Immunotoxicol. 2007;29(3-4):477-86. doi: 10.1080/08923970701675085.</citation>
    <PMID>18075859</PMID>
  </reference>
  <reference>
    <citation>Huitink JM, Heimerikxs M, Nieuwland M, Loer SA, Brugman W, Velds A, Sie D, Kerkhoven RM. Volatile anesthetics modulate gene expression in breast and brain tumor cells. Anesth Analg. 2010 Dec;111(6):1411-5. doi: 10.1213/ANE.0b013e3181fa3533. Epub 2010 Oct 1.</citation>
    <PMID>20889943</PMID>
  </reference>
  <reference>
    <citation>Wigmore TJ, Mohammed K, Jhanji S. Long-term Survival for Patients Undergoing Volatile versus IV Anesthesia for Cancer Surgery: A Retrospective Analysis. Anesthesiology. 2016 Jan;124(1):69-79. doi: 10.1097/ALN.0000000000000936.</citation>
    <PMID>26556730</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>March 14, 2022</last_update_submitted>
  <last_update_submitted_qc>March 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>propofol</keyword>
  <keyword>sevoflurane</keyword>
  <keyword>cancer surgery</keyword>
  <keyword>circulating tumor cells</keyword>
  <keyword>paediatric</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Neoplastic Cells, Circulating</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Sevoflurane</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04475705
org study id: HKCH-REC-2020-013
nct id: NCT04475705
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: single blind controlled trial
primary purpose: Treatment
masking: Single (Participant)
measure: difference in Hypoxia Inducible Factor-1 gene expression
time frame: intraoperative to postoperative 24 hours
description: pg/mL
measure: difference in levels of Interleukin-6
time frame: intraoperative to postoperative 24 hours
description: pg/mL
measure: difference in levels of Tumor Necrosis Factor-alpha
time frame: intraoperative to postoperative 24 hours
description: pg/mL
measure: difference in levels of high sensitivity C reaction protein
time frame: intraoperative to postoperative 24 hours
description: mg/L
measure: difference in levels of DNA damage (Comet Assay)
time frame: intraoperative to postoperative 24 hours
description: %T (percent tail)
measure: difference in levels of Glutathione Peroxidase
time frame: intraoperative to postoperative 24 hours
description: μg/mL
measure: difference in levels of Superoxide dismutase
time frame: intraoperative to postoperative 24 hours
description: units/ml
measure: difference in levels of urinary 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-oxodG)
time frame: intraoperative to postoperative 24 hours
description: ng/mL
measure: difference in levels of 8-oxo-7,8-dihydroguanosine (8-oxoGuo)
time frame: intraoperative to postoperative 24 hours
description: ng/mL
measure: difference in the quantity of circulating tumor cells (CTC)
time frame: intraoperative to postoperative 24 hours
description: cells/100 µL
measure: cancer free survival at 1 and 3 years
time frame: intraoperative to postoperative 24 hours
description: percent
arm group label: Sevoflurane group
arm group type: Active Comparator
description: 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.
arm group label: propofol group
arm group type: Active Comparator
description: 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.
intervention type: Drug
intervention name: propofol
description: intravenous propofol using Target Controlled Infusion 'Paedfusor' model 2-5 as the main anaesthetic to achieve Bispectral Index 40-60
arm group label: propofol group
other name: Diprivan
intervention type: Drug
intervention name: sevoflurane
description: sevoflurane at Minimal Alveolar Concentration 0.7-1.3 as the main anaesthetic to achieve Bispectral Index 40-60.
arm group label: Sevoflurane group
other name: ultane, sevorane
criteria: 
gender: All
minimum age: 6 Months
maximum age: 18 Years
healthy volunteers: No
last name: Sau Man Lee, MBBS
role: Principal Investigator
affiliation: Hong Kong Children's Hospital
last name: Sau Man Lee, MBBS
phone: +85257413327
email: lsm335@gmail.com
last name: Vivian Yuen, MBBS
phone: +85235133752
email: yuenmyv@ha.org.hk
facility: 
status: Recruiting
contact: 
contact backup: 
country: Hong Kong
citation: Divatia JV, Ambulkar R. Anesthesia and cancer recurrence: What is the evidence? J Anaesthesiol Clin Pharmacol. 2014 Apr;30(2):147-50. doi: 10.4103/0970-9185.129990. No abstract available.
PMID: 24803747
citation: Heaney A, Buggy DJ. Can anaesthetic and analgesic techniques affect cancer recurrence or metastasis? Br J Anaesth. 2012 Dec;109 Suppl 1:i17-i28. doi: 10.1093/bja/aes421.
PMID: 23242747
citation: Vinay DS, Ryan EP, Pawelec G, Talib WH, Stagg J, Elkord E, Lichtor T, Decker WK, Whelan RL, Kumara HMCS, Signori E, Honoki K, Georgakilas AG, Amin A, Helferich WG, Boosani CS, Guha G, Ciriolo MR, Chen S, Mohammed SI, Azmi AS, Keith WN, Bilsland A, Bhakta D, Halicka D, Fujii H, Aquilano K, Ashraf SS, Nowsheen S, Yang X, Choi BK, Kwon BS. Immune evasion in cancer: Mechanistic basis and therapeutic strategies. Semin Cancer Biol. 2015 Dec;35 Suppl:S185-S198. doi: 10.1016/j.semcancer.2015.03.004. Epub 2015 Mar 25.
PMID: 25818339
citation: Demicheli R, Retsky MW, Hrushesky WJ, Baum M, Gukas ID. The effects of surgery on tumor growth: a century of investigations. Ann Oncol. 2008 Nov;19(11):1821-8. doi: 10.1093/annonc/mdn386. Epub 2008 Jun 10.
PMID: 18550576
citation: Tavare AN, Perry NJ, Benzonana LL, Takata M, Ma D. Cancer recurrence after surgery: direct and indirect effects of anesthetic agents. Int J Cancer. 2012 Mar 15;130(6):1237-50. doi: 10.1002/ijc.26448. Epub 2011 Nov 9.
PMID: 21935924
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responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Neoplastic Cells, Circulating
mesh term: Propofol
mesh term: Sevoflurane
sharing ipd: No