ER sedation gets a tech upgrade: Computer-Controlled propofol tested
NCT ID NCT03783494
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a computer-controlled method of giving propofol sedation to 45 adults in the emergency department. The goal was to find the right brain concentration needed for deep sedation during painful procedures like fixing a broken bone or putting a dislocated joint back in place. Researchers hope this approach can reduce side effects like low blood pressure or breathing problems that can happen with manual dosing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- propofol
- What this could lead to
- If successful, this could lead to a safer, more precise way to sedate patients in the emergency room for painful procedures.
- What could go wrong
- This is a small, single-center study with only 45 participants, so results may not apply broadly. The technique is new to emergency settings and may not improve safety or outcomes as hoped.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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45 people
The number who actually took part.
- Started
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May 2019
- Finished
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Oct 2020
- 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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * Age of 18 or more * Affiliated or beneficiary of a French health insurance system * Indication of procedural sedation, by the emergency department physician in the context of the management of for a patient with an orthopedic lesion requiring a potentially painful emergentcy therapeutic actionprocedure (reduction of a joint dislocation or realignment of a limb displaced fracture) * For women : * at childbearing age : effective contraception (oral, intra-uterine device or condoms) * postmenopausal : amenorrhea for at least 12 month before the inclusion day * objective infertility (diagnosis or surgically) * Signed free informed consent or inclusion in the context of an emergency situation Exclusion Criteria: * Patient of more than 18 under legal protection or deprivation of liberty measures * Ongoing pregnancy or breastfeeding women * Patient with the incapacity to give his free informed consent, excepted if the incapacity is induced by the context of the emergency situation (inclusion in the context of an emergency situation) * Known hypersensitivity to propofol or one of the excipients, egg, sojasoya or peanuts * ASA comorbidity score of 4 or more * Heart, respiratory, renal or hepatic failure * Epilepsy * Lipid metabolism disorder * Mitochondrial disease * Hemodynamic instability, multiple traumatism * Elevated intracranial tension * Drug or alcohol intoxication * Simultaneous participation to another interventional study
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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
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Emergency Department
Nice, 06000, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.