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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: July 30, 2021

Interventions

  • Procedure: Skin conductance guided antinociception
    • The value of skin conductance guides the titration of sufentanil
  • Procedure: Standard care antinociception
    • The intensive care team titrates antinociception based on their standard approach (using a clinical approach by assessing blood pressure, heart rate, and ventilator dyssynchrony).

Arms, Groups and Cohorts

  • Experimental: Skin conductance guided
    • Sufentanil is titrated by the intensive care team to maintain skin conductance in target
  • Active Comparator: Standard care
    • Sufentanil is titrated at the discretion of the intensivist

Clinical Trial Outcome Measures

Primary Measures

  • Concentration of sufentanil requirements
    • Time Frame: one day to 2 weeks
    • Sufentanil requirements (µg/kg/h)

Secondary Measures

  • Concentration of propofol requirements
    • Time Frame: one day to 2 weeks
    • Propofol requirements (mg/kg/h)
  • Concentration of noradrenaline requirements (concentration of)
    • Time Frame: one day to 2 weeks
    • noradrenaline requirements (µg/kg/min)
  • Intubation time
    • Time Frame: one day to 2 weeks
    • Total time of mechanical ventilation (intubated)
  • Composite post extubation related complications
    • Time Frame: one day to 2 weeks
    • post extubation opioid related complications (e.g., delirium, vomiting, nausea, ileus, respiratory acidosis, hypoxemia, reintubation).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Erasme University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Fabio Taccone, Principal Investigator, Université Libre de Bruxelles
  • Overall Contact(s)
    • Sean Coeckelenbergh, 32 (0) 2 555 39 19, sean.coeckelenbergh@ulb.be

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