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Clinical Trials/NCT04696016
NCT04696016UnknownNot Applicable

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

Erasme University Hospital0 sites30 target enrollmentStarted: February 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
30
Primary Endpoint
Concentration of sufentanil requirements

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Concentration of sufentanil requirements

Time Frame: one day to 2 weeks

Sufentanil requirements (µg/kg/h)

Secondary Outcomes

  • Concentration of propofol requirements(one day to 2 weeks)
  • Concentration of noradrenaline requirements (concentration of)(one day to 2 weeks)
  • Composite post extubation related complications(one day to 2 weeks)
  • Intubation time(one day to 2 weeks)

Investigators

Sponsor
Erasme University Hospital
Sponsor Class
Other
Responsible Party
Sponsor

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