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Anesthesia, TIVA, Balanced Anesthesia, NK Cell

Primary Purpose

Colorectal Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
anesthetic method
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Colorectal cancer patients undergoing elective cytoreductive surgery and HIPEC (20-70 yrs old) American Society of Anesthesiologists physical status I, II, III Exclusion Criteria: Patients under 20 years old. Patients with long-term steroid therapy or immunosuppressive therapy. Patients with long-term NSAIDs therapy. Patients who cannot communicate with other person or with cognitive disorder. Patients who cannot read the consent form.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    TIVA group

    Balanced anesthesia group.

    Arm Description

    In TIVA group, anesthesia will be maintained by propofol and remifentanil infusion under target controlled infusion. Other names: fresofol MCT 1% inj®; Fresenius kabi, Seoul, Korea, Ultian inj®; Hanlim, Seoul, Korea

    Anesthesia will be maintained by sevoflurane and remifentanil infusion in the balanced anesthesia group. Other names: Sojourn®, Kyongbo, Seoul, Korea, Ultian inj®; Hanlim, Seoul, Korea,

    Outcomes

    Primary Outcome Measures

    Postoperative immune function (NK cell count)
    Postoperative immune function will be measured at baseline, POD#1, and POD#7. Postoperative immune function will be investigated by measuring NK cell count.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 1, 2018
    Last Updated
    July 11, 2023
    Sponsor
    Gangnam Severance Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05951842
    Brief Title
    Anesthesia, TIVA, Balanced Anesthesia, NK Cell
    Official Title
    The Differences Between the Effects of Total Intravenous Anesthesia (TIVA) and Balanced Anesthesia on NK Cell and Cytokine Response in Colorectal Cancer Patients Undergoing Cytoreductive Surgery and HIPEC(Hyperthermic Intraperitoneal Chemotherapy)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    participants are no longer being examined or receiving intervention
    Study Start Date
    April 16, 2018 (Actual)
    Primary Completion Date
    February 28, 2020 (Actual)
    Study Completion Date
    February 28, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gangnam Severance Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Anesthetic method was reported to have an impact on postoperative long-term outcome in cancer patients. In this study, we will investigate the effect of different anesthetic methods on NK cell activity, cytokine response and postoperative outcome in colorectal cancer patients undergoing CRS and HIPEC. We will compare propofol-based total intravenous anesthesia (TIVA) with balanced anesthesia to determine the effect of propofol, inhalation agent, and opioid on tumor genesis, recurrence, NK cell activity, cytokine response, and postoperative outcome.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TIVA group
    Arm Type
    Active Comparator
    Arm Description
    In TIVA group, anesthesia will be maintained by propofol and remifentanil infusion under target controlled infusion. Other names: fresofol MCT 1% inj®; Fresenius kabi, Seoul, Korea, Ultian inj®; Hanlim, Seoul, Korea
    Arm Title
    Balanced anesthesia group.
    Arm Type
    Experimental
    Arm Description
    Anesthesia will be maintained by sevoflurane and remifentanil infusion in the balanced anesthesia group. Other names: Sojourn®, Kyongbo, Seoul, Korea, Ultian inj®; Hanlim, Seoul, Korea,
    Intervention Type
    Drug
    Intervention Name(s)
    anesthetic method
    Intervention Description
    Patients will be assigned to one of the groups, TIVA group or Balanced anesthesia group. In TIVA group, anesthesia will be maintained by propofol and remifentanil infusion under target controlled infusion. In contrast, anesthesia will be maintained by sevoflurane and remifentanil infusion in the balanced anesthesia group.
    Primary Outcome Measure Information:
    Title
    Postoperative immune function (NK cell count)
    Description
    Postoperative immune function will be measured at baseline, POD#1, and POD#7. Postoperative immune function will be investigated by measuring NK cell count.
    Time Frame
    Postoperative day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Colorectal cancer patients undergoing elective cytoreductive surgery and HIPEC (20-70 yrs old) American Society of Anesthesiologists physical status I, II, III Exclusion Criteria: Patients under 20 years old. Patients with long-term steroid therapy or immunosuppressive therapy. Patients with long-term NSAIDs therapy. Patients who cannot communicate with other person or with cognitive disorder. Patients who cannot read the consent form.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Anesthesia, TIVA, Balanced Anesthesia, NK Cell

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