Nociceptive PainNCT04696016
Guiding Sufentanil Administration With Skin Conductance in Mechanically Ventilated Intensive Care Patients
A study testing Skin conductance guided antinociception in people with Nociceptive Pain, run by Erasme University Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Nociceptive Pain
- What is being tested?
- Skin conductance guided antinociception
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient admitted to the ICU requiring endotracheal intubation, antinociception, and sedation
Who cannot join
- Traumatic brain injury
- use of ketamine, dexmedetomidine, or clonidine
- pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- Skin conductance guided antinociception, Standard care antinociception
- Medical subject headings
- Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin conductance guided antinociceptionProcedure or surgery
The value of skin conductance guides the titration of sufentanil
Standard care antinociceptionProcedure or surgery
The intensive care team titrates antinociception based on their standard approach (using a clinical approach by assessing blood pressure, heart rate, and ventilator dyssynchrony).
| Study group | Role | What they receive |
|---|---|---|
| Skin conductance guided | Experimental | Sufentanil is titrated by the intensive care team to maintain skin conductance in target Receives: Procedure: Skin conductance guided antinociception |
| Standard care | Active comparator | Sufentanil is titrated at the discretion of the intensivist Receives: Procedure: Standard care antinociception |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of sufentanil requirements
Sufentanil requirements (µg/kg/h)
Measured: one day to 2 weeks
Secondary outcomes (4)
Concentration of propofol requirements
Propofol requirements (mg/kg/h)
Measured: one day to 2 weeks
Concentration of noradrenaline requirements (concentration of)
noradrenaline requirements (µg/kg/min)
Measured: one day to 2 weeks
Intubation time
Total time of mechanical ventilation (intubated)
Measured: 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).
Measured: one day to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Feb 2021 (estimated)
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nociceptive PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabio Taccone, Principal investigator, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696016
- Sponsor's protocol ID
- P2020/402 / B4062020000124
- Status last verified
- Feb 2021
- First submitted
- 4 Jan 2021
- Last updated
- 3 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guiding Sufentanil Administration With Skin Conductance in Mechanically Ventilated Intensive Care Patients
- ClinicalTrials.gov ID
- NCT04696016
- Acronym / sponsor ID
- P2020/402 / B4062020000124
- Conditions
- Nociceptive Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin conductance guided | Experimental | Procedure: Skin conductance guided antinociceptionSufentanil is titrated by the intensive care team to maintain skin conductance in target |
| Standard care | Active comparator | Procedure: Standard care antinociceptionSufentanil is titrated at the discretion of the intensivist |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patient admitted to the ICU requiring endotracheal intubation, antinociception, and sedation
Key exclusion criteria (3 listed)
- Traumatic brain injury
- use of ketamine, dexmedetomidine, or clonidine
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin conductance guided antinociceptionThe value of skin conductance guides the titration of sufentanil | Procedure or surgery | Skin conductance guided |
| Standard care antinociceptionThe intensive care team titrates antinociception based on their standard approach (using a clinical approach by assessing blood pressure, heart rate, and ventilator dyssynchrony). | Procedure or surgery | Standard care |
Primary outcome
Concentration of sufentanil requirements
Time frame: one day to 2 weeks
Sufentanil requirements (µg/kg/h)
4 secondary outcomes
Concentration of propofol requirements
Time frame: one day to 2 weeks
Concentration of noradrenaline requirements (concentration of)
Time frame: one day to 2 weeks
Intubation time
Time frame: one day to 2 weeks
Composite post extubation related complications
Time frame: one day to 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Taccone principal investigator
Université Libre de Bruxelles
Questions about this trial
What is this clinical trial studying?
A study testing Skin conductance guided antinociception in people with Nociceptive Pain, run by Erasme University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sean Coeckelenbergh (32 (0) 2 555 39 19, sean.coeckelenbergh@ulb.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of sufentanil requirements (time frame: one day to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.