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Comparison Of Epidural Analgesia Techniques In Percutaneous Nephrolithotomy With Surgical Pleth Index

Primary Purpose

Analgesia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TRADITIONAL EPIDURAL
DURAL PUNCTURE EPIDURAL
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • aged 18-60
  • ASA I-III
  • grade I unilateral PNL

Exclusion Criteria:

  • BMI > 40 kg/m2
  • drug or alcohol abuse history in the last 6 mounts
  • chronic opoid usage or had chronic pain longer than 6 weeks
  • peripheral and central neurological disorders
  • preoperative hemodynamic disorders
  • irregular sinus rhythm and pace makers
  • diabetes, severe lung and major liver diseases with increasing biluribin
  • use of anti-muscarinics, α2-adrenergic agonists, β1-adrenergic agonists, anti arrhythmic; who used chronic psychoactive drugs in last 90 days
  • who are pregnant and breast feeding
  • not willing to participate
  • allergic or intolerant to any of the drugs in the study
  • procedures that take less than 2 hours

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    TRADITIONAL EPIDURAL

    DURAL PUNCTURE EPIDURAL

    Arm Description

    standard epidural technique used for intraoperative analgesia (the EPL group; local anesthetics will be delivered via epidural catheter guided by SPI to provide intraoperative analgesia

    group on whom dural puncture epidural technique used for intraoperative analgesia ( the DPL group; local anesthetics will be delivered via an epidural catheter placed after a dural pucture performed with the SPI guidance to provide intraoperative analgesia)

    Outcomes

    Primary Outcome Measures

    consumption of local aneshesics
    to evaluate affect of SPI guided antinociception on total intraoperative consumption of local aneshesics during analgesia

    Secondary Outcome Measures

    time interval and SPI value dropping
    defining time interval between LA administration and SPI value dropping under 50 and hemodynamy
    local anesthesic consumption
    total mean local anesthesic consumption per hour, mean LA bolus number, total norepinephrine, ephedrine and atrophine consumption, mean intraoperative heart rate, mean arterial pressure, BIS and minimal alveolar concentration, percentage of intraoperative surgery time during which SPI>50, time passed until first post operative analgesia need, time needed to be discharged from PACU after operation (evaluated via Aldrte score) and post operative side effects (nausea, vomiting, sedatition and piruritis)

    Full Information

    First Posted
    September 13, 2022
    Last Updated
    October 6, 2022
    Sponsor
    Ataturk University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05572164
    Brief Title
    Comparison Of Epidural Analgesia Techniques In Percutaneous Nephrolithotomy With Surgical Pleth Index
    Official Title
    Comparison On Efficiency Of Surgical Pleth Index-Guided Traditional Epidural And Dural Puncture Epidural Analgesia Techniques In Percutaneous Nephrolithotomy: A Randomised Double Blind Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2022 (Anticipated)
    Primary Completion Date
    October 1, 2023 (Anticipated)
    Study Completion Date
    December 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ataturk University

    4. Oversight

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

    5. Study Description

    Brief Summary
    Primary aim of this study is to evaluate affect of SPI guided antinociception on total intraoperative consumption of local aneshesics during analgesia. Secondary aims are defining time interval between LA administration and SPI value dropping under 50 and hemodynamy. Tertiary results are total mean local anesthesic consumption per hour, mean LA bolus number, total norepinephrine, ephedrine and atrophine consumption, mean intraoperative heart rate, mean arterial pressure, BIS and minimal alveolar concentration, percentage of intraoperative surgery time during which SPI>50, time passed until first post operative analgesia need, time needed to be discharged from PACU after operation (evaluated via Aldrte score) and post operative side effects (nausea, vomiting, sedatition and piruritis)

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TRADITIONAL EPIDURAL
    Arm Type
    Active Comparator
    Arm Description
    standard epidural technique used for intraoperative analgesia (the EPL group; local anesthetics will be delivered via epidural catheter guided by SPI to provide intraoperative analgesia
    Arm Title
    DURAL PUNCTURE EPIDURAL
    Arm Type
    Active Comparator
    Arm Description
    group on whom dural puncture epidural technique used for intraoperative analgesia ( the DPL group; local anesthetics will be delivered via an epidural catheter placed after a dural pucture performed with the SPI guidance to provide intraoperative analgesia)
    Intervention Type
    Procedure
    Intervention Name(s)
    TRADITIONAL EPIDURAL
    Intervention Description
    epidural technique used for intraoperative analgesia (the EPL group; local anesthetics will be delivered via epidural catheter guided by SPI to provide intraoperative analgesia)
    Intervention Type
    Procedure
    Intervention Name(s)
    DURAL PUNCTURE EPIDURAL
    Intervention Description
    group on whom dural puncture epidural technique used for intraoperative analgesia ( the DPL group; local anesthetics will be delivered via an epidural catheter placed after a dural pucture performed with the SPI guidance to provide intraoperative analgesia)
    Primary Outcome Measure Information:
    Title
    consumption of local aneshesics
    Description
    to evaluate affect of SPI guided antinociception on total intraoperative consumption of local aneshesics during analgesia
    Time Frame
    intraoperative
    Secondary Outcome Measure Information:
    Title
    time interval and SPI value dropping
    Description
    defining time interval between LA administration and SPI value dropping under 50 and hemodynamy
    Time Frame
    intraoperative
    Title
    local anesthesic consumption
    Description
    total mean local anesthesic consumption per hour, mean LA bolus number, total norepinephrine, ephedrine and atrophine consumption, mean intraoperative heart rate, mean arterial pressure, BIS and minimal alveolar concentration, percentage of intraoperative surgery time during which SPI>50, time passed until first post operative analgesia need, time needed to be discharged from PACU after operation (evaluated via Aldrte score) and post operative side effects (nausea, vomiting, sedatition and piruritis)
    Time Frame
    during the procedure/surgery and during 30 minutes of PACU stay

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: aged 18-60 ASA I-III grade I unilateral PNL Exclusion Criteria: BMI > 40 kg/m2 drug or alcohol abuse history in the last 6 mounts chronic opoid usage or had chronic pain longer than 6 weeks peripheral and central neurological disorders preoperative hemodynamic disorders irregular sinus rhythm and pace makers diabetes, severe lung and major liver diseases with increasing biluribin use of anti-muscarinics, α2-adrenergic agonists, β1-adrenergic agonists, anti arrhythmic; who used chronic psychoactive drugs in last 90 days who are pregnant and breast feeding not willing to participate allergic or intolerant to any of the drugs in the study procedures that take less than 2 hours
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ayşenur Dostbil
    Phone
    +905333677796
    Email
    adostbil@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ayşenur Dostbil
    Organizational Affiliation
    Ataturk University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison Of Epidural Analgesia Techniques In Percutaneous Nephrolithotomy With Surgical Pleth Index

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