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Guiding Sufentanil Administration With Skin Conductance in Mechanically Ventilated Intensive Care Patients

Primary Purpose

Nociceptive Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Skin conductance guided antinociception
Standard care antinociception
Sponsored by
Erasme University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nociceptive Pain

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patient admitted to the ICU requiring endotracheal intubation, antinociception, and sedation

Exclusion Criteria:

  • Traumatic brain injury
  • use of ketamine, dexmedetomidine, or clonidine
  • pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Skin conductance guided

    Standard care

    Arm Description

    Sufentanil is titrated by the intensive care team to maintain skin conductance in target

    Sufentanil is titrated at the discretion of the intensivist

    Outcomes

    Primary Outcome Measures

    Concentration of sufentanil requirements
    Sufentanil requirements (µg/kg/h)

    Secondary Outcome Measures

    Concentration of propofol requirements
    Propofol requirements (mg/kg/h)
    Concentration of noradrenaline requirements (concentration of)
    noradrenaline requirements (µg/kg/min)
    Intubation time
    Total time of mechanical ventilation (intubated)
    Composite post extubation related complications
    post extubation opioid related complications (e.g., delirium, vomiting, nausea, ileus, respiratory acidosis, hypoxemia, reintubation).

    Full Information

    First Posted
    January 4, 2021
    Last Updated
    February 1, 2021
    Sponsor
    Erasme University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04696016
    Brief Title
    Guiding Sufentanil Administration With Skin Conductance in Mechanically Ventilated Intensive Care Patients
    Official Title
    Guiding Sufentanil Administration With Skin Conductance in Mechanically Ventilated Intensive Care Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2021 (Anticipated)
    Primary Completion Date
    July 30, 2021 (Anticipated)
    Study Completion Date
    July 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Erasme University Hospital

    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
    Opioid administration in mechanically ventilated patients in the intensive care unit (ICU) is essential to maintaining patient respiratory and hemodynamic stability. Mechanical ventilation is a persistently nociceptive event that can continuously causes discomfort in the trachealy intubated patient. This can lead to patient-ventilator dyssynchrony, tachycardia, hypertension, and their associated complications. Opioids blunt respiratory drive, which facilitates mechanical ventilation, and decrease the sympathetic response to nociception. However, excessive opiate administration is associated with many adverse events, including respiratory depression, delirium, ileus, nausea, and vomiting. Currently, the standard administration in our institution of sufentanil, a potent opiate, consists of continuous infusions of 0.15µg/kg/h to 0.3µg/kg/h. Mechanically ventilated patients are unable to speak and are often sedated. This greatly impacts the patient's capacity to communicate pain. The use of a nociceptive monitor may be a possible solution. Skin conductance monitoring (Pain Monitor, Med-Storm, Norway), measures the peaks per second of electrical conduction. This non hemodynamic monitor uses skin conduction as a surrogate to nociception (i.e., the patient's unconscious response to a noxious stimulus). It may consequently guide opioid administration in ICU patients towards and avoid the consequences of excessive or inadequate antinociception.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Skin conductance guided
    Arm Type
    Experimental
    Arm Description
    Sufentanil is titrated by the intensive care team to maintain skin conductance in target
    Arm Title
    Standard care
    Arm Type
    Active Comparator
    Arm Description
    Sufentanil is titrated at the discretion of the intensivist
    Intervention Type
    Procedure
    Intervention Name(s)
    Skin conductance guided antinociception
    Intervention Description
    The value of skin conductance guides the titration of sufentanil
    Intervention Type
    Procedure
    Intervention Name(s)
    Standard care antinociception
    Intervention Description
    The intensive care team titrates antinociception based on their standard approach (using a clinical approach by assessing blood pressure, heart rate, and ventilator dyssynchrony).
    Primary Outcome Measure Information:
    Title
    Concentration of sufentanil requirements
    Description
    Sufentanil requirements (µg/kg/h)
    Time Frame
    one day to 2 weeks
    Secondary Outcome Measure Information:
    Title
    Concentration of propofol requirements
    Description
    Propofol requirements (mg/kg/h)
    Time Frame
    one day to 2 weeks
    Title
    Concentration of noradrenaline requirements (concentration of)
    Description
    noradrenaline requirements (µg/kg/min)
    Time Frame
    one day to 2 weeks
    Title
    Intubation time
    Description
    Total time of mechanical ventilation (intubated)
    Time Frame
    one day to 2 weeks
    Title
    Composite post extubation related complications
    Description
    post extubation opioid related complications (e.g., delirium, vomiting, nausea, ileus, respiratory acidosis, hypoxemia, reintubation).
    Time Frame
    one day to 2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patient admitted to the ICU requiring endotracheal intubation, antinociception, and sedation Exclusion Criteria: Traumatic brain injury use of ketamine, dexmedetomidine, or clonidine pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sean Coeckelenbergh
    Phone
    32 (0) 2 555 39 19
    Email
    sean.coeckelenbergh@ulb.be
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fabio Taccone
    Organizational Affiliation
    Université Libre de Bruxelles
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Guiding Sufentanil Administration With Skin Conductance in Mechanically Ventilated Intensive Care Patients

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