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The MEC90 of Epidural Ropivacaine Blunting Hemodynamic Changes to Pneumoperitoneum

Primary Purpose

Laparoscopic Gastrectomy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ropivacaine
Sponsored by
Keimyung University Dongsan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Laparoscopic Gastrectomy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients undergoing laparoscopic gastrectomy that require pneumoperitoneum
  • patients who has epidural catheter to manage postoperative pain control
  • patients who agree to our study

Exclusion Criteria:

  • patients who don't agree to our study
  • BMI<16.0 or BMI>35
  • cardiovascular disease, pulmonary disease, renal disease
  • alcoholic abuser or drug abuser
  • any use of local anesthetics or drugs which have an influence on cardiovascular system from beginning of induction

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    laparoscopic gastrectomy with pneumoperitoneum

    Arm Description

    Outcomes

    Primary Outcome Measures

    Changes from baseline in heart rate (bpm) after CO2 insufflation
    Heart rate will be recorded before anesthesia induction, during CO2 insufflation, after Co2 insufflation. The mean value of heart rate before anesthesia induction will be regarded as the baseline values. If maximum heart rate after Co2 insufflation increased by >20% from baseline value, the response will be regarded as "fail" and increased concentration of ropivacaine will be applied to next patient by up and down method.
    Changes from baseline in mean arterial pressure (mmHg) after CO2
    Mean arterial pressure will be recorded before anesthesia induction, during CO2 insufflation, after Co2 insufflation. The mean value of mean arterial pressure before anesthesia induction will be regarded as the baseline values. If maximum mean arterial pressure after Co2 insufflation increased by >20% from baseline value, the response will be regarded as "fail" and increased concentration of ropivacaine will be applied to next patient by up and down method.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 23, 2020
    Last Updated
    January 29, 2020
    Sponsor
    Keimyung University Dongsan Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04247373
    Brief Title
    The MEC90 of Epidural Ropivacaine Blunting Hemodynamic Changes to Pneumoperitoneum
    Official Title
    The MEC90 of Epidural Ropivacaine Blunting Hemodynamic Changes to Pneumoperitoneum in the Patients Undergoing Laparoscopic Gastrectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2020 (Anticipated)
    Primary Completion Date
    August 2020 (Anticipated)
    Study Completion Date
    August 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Keimyung University Dongsan Medical Center

    4. Oversight

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

    5. Study Description

    Brief Summary
    Investigators want to find the concentration of epidural ropivacaine, which can block hemodynamic changes in the onset of pneumoperitoneum in the laparoscopic gastrectomy.
    Detailed Description
    According to previous patient's response, the investigators will allocate the concentration of ropivacaine of next patient during Co2 insufflation. And, for this allocation of concentration of ropivacaine, the investigators use biased coin design up-and-down method. Based on the practices, the starting concentration is 0.375 %, and the step size of concentration is 0.125%.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Laparoscopic Gastrectomy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    laparoscopic gastrectomy with pneumoperitoneum
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine
    Intervention Description
    According to previous patient's response, the investigators will allocate the concentration of ropivacaine of next patient during Co2 insufflation. And, for this allocation of concentration of ropivacaine the investigators use biased coin design up-and-down method.
    Primary Outcome Measure Information:
    Title
    Changes from baseline in heart rate (bpm) after CO2 insufflation
    Description
    Heart rate will be recorded before anesthesia induction, during CO2 insufflation, after Co2 insufflation. The mean value of heart rate before anesthesia induction will be regarded as the baseline values. If maximum heart rate after Co2 insufflation increased by >20% from baseline value, the response will be regarded as "fail" and increased concentration of ropivacaine will be applied to next patient by up and down method.
    Time Frame
    immediately after CO2 insufflation : 1,2,3,4,5,6, 7, 8, 9, 10 minutes after CO2 insufflation
    Title
    Changes from baseline in mean arterial pressure (mmHg) after CO2
    Description
    Mean arterial pressure will be recorded before anesthesia induction, during CO2 insufflation, after Co2 insufflation. The mean value of mean arterial pressure before anesthesia induction will be regarded as the baseline values. If maximum mean arterial pressure after Co2 insufflation increased by >20% from baseline value, the response will be regarded as "fail" and increased concentration of ropivacaine will be applied to next patient by up and down method.
    Time Frame
    immediately after CO2 insufflation : 1,2,3,4,5,6, 7, 8, 9, 10 minutes after CO2 insufflation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients undergoing laparoscopic gastrectomy that require pneumoperitoneum patients who has epidural catheter to manage postoperative pain control patients who agree to our study Exclusion Criteria: patients who don't agree to our study BMI<16.0 or BMI>35 cardiovascular disease, pulmonary disease, renal disease alcoholic abuser or drug abuser any use of local anesthetics or drugs which have an influence on cardiovascular system from beginning of induction
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jiwon Lee, Dr
    Phone
    +82532587770
    Email
    belief705@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hyung-wook Lim
    Phone
    82532506691
    Email
    irbdsmc@naver.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    JIWON LEE, Dr
    Organizational Affiliation
    Dongsan Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The MEC90 of Epidural Ropivacaine Blunting Hemodynamic Changes to Pneumoperitoneum

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