Smart device aims to cut pain drug use during surgery
NCT ID NCT03556696
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a medical device that automatically gives the pain drug remifentanil during surgery, based on heart rate, blood pressure, and a pain index. 52 adults having burn surgery took part. The goal was to see if the device could reduce the total amount of pain medicine needed compared to standard dosing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Remifentanil
- What this could lead to
- If it works, this could lead to more precise pain control during surgery, potentially reducing side effects and drug use.
- What could go wrong
- This is a small, early-stage study with only 52 participants. The device may not work better than standard practice, and results may not apply to other surgeries or patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
52 people
The number who actually took part.
- Started
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Jun 2018
- Finished
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Nov 2022
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * ASA 1, 2 or 3 adult patients scheduled to undergo burn wound surgery at the Burn Center of the University Hospital of Lille Exclusion Criteria: * BMI outside \[17 - 35 kg/m2\] * pregnancy or breast feeding women * non sinus cardiac rhythm * documented dysautonomia * complicated diabetes mellitus * known allergy to a drug used in the clinical trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hôpital Roger Salengro, CHU
Lille, France
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