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

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.

Study Overview

• Status: Unknown
• Conditions: Nociceptive Pain
• Intervention / Treatment: Procedure: Skin conductance guided antinociception; Procedure: Standard care antinociception

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Skin conductance guided; Sufentanil is titrated by the intensive care team to maintain skin conductance in target	Procedure: Skin conductance guided antinociception; The value of skin conductance guides the titration of sufentanil
ACTIVE_COMPARATOR: Standard care; Sufentanil is titrated at the discretion of the intensivist	Procedure: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of sufentanil requirements	Sufentanil requirements (µg/kg/h)	one day to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of propofol requirements	Propofol requirements (mg/kg/h)	one day to 2 weeks
Concentration of noradrenaline requirements (concentration of)	noradrenaline requirements (µg/kg/min)	one day to 2 weeks
Intubation time	Total time of mechanical ventilation (intubated)	one day to 2 weeks
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

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Investigators: Principal Investigator: Fabio Taccone, Université libre de Bruxelles

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2021
• Primary Completion (ANTICIPATED): July 30, 2021
• Study Completion (ANTICIPATED): July 30, 2021

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (ACTUAL): January 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nociceptive Pain
• Other Study ID Numbers: P2020/402 / B4062020000124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No