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

Nociceptive Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04696016
• Other study ID #: P2020/402 / B4062020000124
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: July 30, 2021

Study information

• Verified date: February 2021
• Source: Erasme University Hospital
• Contact: Sean Coeckelenbergh
• Phone: 32 (0) 2 555 39 19
• Email: sean.coeckelenbergh[@]ulb.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Nociceptive Pain

Intervention

Procedure:
• Skin conductance guided antinociception
The value of skin conductance guides the titration of sufentanil
• Standard 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of sufentanil requirements	Sufentanil requirements (µg/kg/h)	one day to 2 weeks
Secondary	Concentration of propofol requirements	Propofol requirements (mg/kg/h)	one day to 2 weeks
Secondary	Concentration of noradrenaline requirements (concentration of)	noradrenaline requirements (µg/kg/min)	one day to 2 weeks
Secondary	Intubation time	Total time of mechanical ventilation (intubated)	one day to 2 weeks
Secondary	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