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

Study Overview
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Brief Summary
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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.

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

Conditions
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Nociceptive Pain

Intervention / Treatment
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* Procedure: Skin conductance guided antinociception
* Procedure: Standard care antinociception


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin conductance guided<br>Sufentanil is titrated by the intensive care team to maintain skin conductance in target | Procedure: Skin conductance guided antinociception<br>* The value of skin conductance guides the titration of sufentanil<br>|
| Active Comparator: Standard care<br>Sufentanil is titrated at the discretion of the intensivist | Procedure: Standard care antinociception<br>* The intensive care team titrates antinociception based on their standard approach (using a clinical approach by assessing blood pressure, heart rate, and ventilator dyssynchrony).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of sufentanil requirements | Sufentanil requirements (µg/kg/h) | one day to 2 weeks | 

Secondary Outcome Measures

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