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

F

Free University of Brussels (ULB)

Status

Unknown

Conditions

Nociceptive Pain

Treatments

Procedure: Standard care antinociception
Procedure: Skin conductance guided antinociception

Study type

Interventional

Funder types

Other

Identifiers

NCT04696016
P2020/402 / B4062020000124

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

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

Trial contacts and locations

0

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Central trial contact

Sean Coeckelenbergh

Data sourced from clinicaltrials.gov

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