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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04696016
Enrollment
30
Registered
2021-01-06
Start date
2021-02-01
Completion date
2021-07-30
Last updated
2021-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nociceptive Pain

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.

Interventions

PROCEDURESkin conductance guided antinociception

The value of skin conductance guides the titration of sufentanil

PROCEDUREStandard 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).

Sponsors

Erasme University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Concentration of sufentanil requirementsone day to 2 weeksSufentanil requirements (µg/kg/h)

Secondary

MeasureTime frameDescription
Concentration of propofol requirementsone day to 2 weeksPropofol requirements (mg/kg/h)
Concentration of noradrenaline requirements (concentration of)one day to 2 weeksnoradrenaline requirements (µg/kg/min)
Intubation timeone day to 2 weeksTotal time of mechanical ventilation (intubated)
Composite post extubation related complicationsone day to 2 weekspost extubation opioid related complications (e.g., delirium, vomiting, nausea, ileus, respiratory acidosis, hypoxemia, reintubation).

Contacts

Primary ContactSean Coeckelenbergh
sean.coeckelenbergh@ulb.be32 (0) 2 555 39 19

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026