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

Not Applicable

• Conditions: Nociceptive Pain
• Interventions: Procedure: Skin conductance guided antinociception; Procedure: Standard care antinociception

• Registration Number: NCT04696016
• Lead Sponsor: Erasme University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-06
• Status Verified: 2021-02
• Study Start: 2021-02-01
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-03
• Primary Completion: 2021-07-30
• Study Completion: 2021-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Skin conductance guided	Skin conductance guided antinociception	Sufentanil is titrated by the intensive care team to maintain skin conductance in target
Standard care	Standard care antinociception	Sufentanil is titrated at the discretion of the intensivist

Primary Outcome Measures

Name	Time	Method
Concentration of sufentanil requirements	one day to 2 weeks	Sufentanil requirements (µg/kg/h)

Secondary Outcome Measures

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