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Different Anesthetic Managements of Esophageal Resection and Reconstruction

Primary Purpose

Anesthesia, Esophagus Cancer, Postoperative Complications

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cardiac Output Maximization
Cardiac Output Normalization
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia focused on measuring Outcome

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed as esophageal cancer
  • Scheduled for minimally invasive esophageal resection and reconstruction

Exclusion Criteria:

  • End-stage organ dysfunction, including heart failure, hepatic failure, renal failure
  • Arrhythmia
  • Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Cardiac Output Maximization

    Cardiac Output Normalization

    Arm Description

    maximize stroke volume, and maintain cardiac index and stroke volume variation during the whole operation

    keep cardiac index (CI) ≥ 2.2, and maintain CI and stroke volume variation during the whole operation

    Outcomes

    Primary Outcome Measures

    Incidence of postoperative complication
    Perioperative mortality, anastomotic leakage, pneumonia, respiratory failure, renal dysfunction, and surgical site infection

    Secondary Outcome Measures

    Intraoperative hemodynamic stability
    Incidence of intraoperative shock, use of vasopressor or inotropic agents
    Length of stay
    Intensive care unit length of stay and hospital stay

    Full Information

    First Posted
    November 6, 2016
    Last Updated
    November 8, 2016
    Sponsor
    National Taiwan University Hospital
    Collaborators
    Ministry of Science and Technology, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02961140
    Brief Title
    Different Anesthetic Managements of Esophageal Resection and Reconstruction
    Official Title
    The Effects of Different Anesthetic Managements on Inflammation, Oxidative Injuries, and Major Organ Complications: a Prospective Investigations on Esophageal Reconstruction and Intraoperative Shock
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2016 (undefined)
    Primary Completion Date
    November 2018 (Anticipated)
    Study Completion Date
    November 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital
    Collaborators
    Ministry of Science and Technology, Taiwan

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Anesthetic management and fluid therapy is crucial in esophageal resection and reconstruction, which is associated with high incidence of postoperative morbidity and mortality. This study aims to investigate the effect of goal directed fluid management on the postoperative outcome of esophageal resection and reconstruction.
    Detailed Description
    Anesthetic management and fluid therapy is crucial in esophageal resection and reconstruction, which is associated with high incidence of postoperative morbidity and mortality. Excessive fluid administration may result in pulmonary complication, while extremely hypovolemia may lead to shock, circulatory dysfunction, and renal damage. Little is known about fluid status will have impact on anastomotic leakage. Goal-directed fluid therapy has shown to benefit perioperative outcome in major abdominal surgery. This study aims to investigate the effect of goal directed fluid management on the postoperative outcome of esophageal resection and reconstruction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anesthesia, Esophagus Cancer, Postoperative Complications
    Keywords
    Outcome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cardiac Output Maximization
    Arm Type
    Experimental
    Arm Description
    maximize stroke volume, and maintain cardiac index and stroke volume variation during the whole operation
    Arm Title
    Cardiac Output Normalization
    Arm Type
    Active Comparator
    Arm Description
    keep cardiac index (CI) ≥ 2.2, and maintain CI and stroke volume variation during the whole operation
    Intervention Type
    Other
    Intervention Name(s)
    Cardiac Output Maximization
    Intervention Description
    According to Frank-Starling law, the investigator will administer Voluven 6% 250 mL every 5 minute until stroke volume maximized (stabilized for 20 minutes), and maintain cardiac index and stroke volume variation during the whole operation.
    Intervention Type
    Other
    Intervention Name(s)
    Cardiac Output Normalization
    Intervention Description
    The investigator will administer intravenous fluids to keep cardiac index (CI) ≥ 2.2, and maintain CI and stroke volume variation during the whole operation.
    Primary Outcome Measure Information:
    Title
    Incidence of postoperative complication
    Description
    Perioperative mortality, anastomotic leakage, pneumonia, respiratory failure, renal dysfunction, and surgical site infection
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Intraoperative hemodynamic stability
    Description
    Incidence of intraoperative shock, use of vasopressor or inotropic agents
    Time Frame
    1 day
    Title
    Length of stay
    Description
    Intensive care unit length of stay and hospital stay
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients diagnosed as esophageal cancer Scheduled for minimally invasive esophageal resection and reconstruction Exclusion Criteria: End-stage organ dysfunction, including heart failure, hepatic failure, renal failure Arrhythmia Pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ya-jung Cheng, M.D., Ph.D
    Phone
    +886-2-23123456
    Ext
    65517
    Email
    chengyj@ntu.edu.tw
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ya-jung Cheng, M.D., Ph.D
    Organizational Affiliation
    National Taiwan University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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