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

NCT04696016 | Unknown

• 1 other identifier: P2020/402 / B4062020000124
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nociceptive Pain

Outcome Measures

Primary Outcomes (1)

• Concentration of sufentanil requirements

  Sufentanil requirements (µg/kg/h)

  one day to 2 weeks

Secondary Outcomes (4)

• Concentration of propofol requirements

  one day to 2 weeks

• Concentration of noradrenaline requirements (concentration of)

  one day to 2 weeks

• Intubation time

  one day to 2 weeks

• Composite post extubation related complications

  one day to 2 weeks

Study Arms (2)

Skin conductance guided

EXPERIMENTAL

Sufentanil is titrated by the intensive care team to maintain skin conductance in target

Procedure: Skin conductance guided antinociception

Standard care

ACTIVE COMPARATOR

Sufentanil is titrated at the discretion of the intensivist

Procedure: Standard care antinociception

Interventions

Skin conductance guided antinociception PROCEDURE

The value of skin conductance guides the titration of sufentanil

Skin conductance guided

Standard care antinociception PROCEDURE

The intensive care team titrates antinociception based on their standard approach (using a clinical approach by assessing blood pressure, heart rate, and ventilator dyssynchrony).

Standard care

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient admitted to the ICU requiring endotracheal intubation, antinociception, and sedation

You may not qualify if:

• Traumatic brain injury
• use of ketamine, dexmedetomidine, or clonidine
• pregnancy

Sponsors & Collaborators

• Erasme University Hospital: lead

MeSH Terms

Conditions

Nociceptive Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fabio Taccone

  Université Libre de Bruxelles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sean Coeckelenbergh

CONTACT

32 (0) 2 555 39 19; sean.coeckelenbergh@ulb.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 6, 2021
• Study Start: February 1, 2021
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: February 3, 2021

Record last verified: 2021-02