Joint DislocationPhase 4SIVOCNCT03783494
Target-controlled Infusion With Propofol in the Emergency Department : a Prospective Study on 45 Adult Patients
A Phase 4 study of Joint Dislocation and Limb Fracture, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Procedural sedation is an emergency medicine technique that provides a brief, deep sedation in order to perform very painful emergency emergent procedures such as displaced fracture or dislocated joints reduction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Dislocation, Limb Fracture
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 9 May 2019to 25 Oct 2020
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- Epilepsy
- Lipid metabolism disorder
- Mitochondrial disease
- Hemodynamic instability, multiple traumatism
- Elevated intracranial tension
- Drug or alcohol intoxication
- Simultaneous participation to another interventional study
Trial locations and contacts
1 site in 1 country.
About this study
Procedural sedation is an emergency medicine technique that provides a brief, deep sedation in order to perform very painful emergency emergent procedures such as displaced fracture or dislocated joints reduction. Propofol is recommended for this purpose, injected administered in slow IV bolus injections according to the technique known as manual titration. But despite this precaution, temporarily excessive sedation can happen, and a side effect can appear (arterial hypotension or respiratory depression). Target-controlled infusion (TCI) is an anesthesia technique that permits to obtain a precise constant and stable concentration of medication, boluses volumes of injection being calculated and delivered automatically by an electric syringe equipped with a software obedient to existing pharmacokinetic models. In the operating room, Ffor anesthetic induction, maintenance and awakening, respectively, in the operating room, the brain concentrations of propofol range respectively from 2 to 6 μg/mL, 2 to 4 μg/mL, and between 0.8 and 1.2 μg/mL, respectively. Since TCI has never been used in emergency departments (ED), the brain propofol concentrations which are necessary for sedation and awakening of the patient are not known and must be determined experimentally.
In this single-center, prospective, interventional study, safety and feasibility of TCI will be studied in one ED with the primary objective of determining the brain propofol concentrations necessary to reach the an optimal sedation in for patients with indications of sustaining very painful orthopedic emergency emergent procedures
Read the detailed description
Procedural sedation is an emergency medicine technique that provides a brief, deep sedation in order to perform very painful emergency emergent procedures such as displaced fracture or dislocated joints reduction. For this purpose, propofol is a remarkable sedative agent for its very short elimination half-life, antiemetic property and myorelaxant effects. It is recommended to inject administer it in slow IV boluses injections according to the technique known as manual titration, but despite this precaution, temporarily excessive sedation can happen, and a side effect appear (arterial hypotension or respiratory depression).
Target-controlled infusion (TCI) is an anesthesia technique that permits to obtain a precise constant and stable concentration of medication, boluses volumes of injection being calculated and delivered automatically by an electric syringe equipped with a software obedient to existing pharmacokinetic models.
The age, size and weight of the patient are filledentered, then the syringe delivers the volume which is necessary and sufficient to reach and maintain the target concentration chosen by the practitioner. For anesthetic induction in the operating room, the brain concentrations of propofol used range from 2 to 6 μg/mL, then the general anesthesia maintenance is obtained with 2 to 4 μg/mL, and the patient awakening usually happens between 0.8 and 1.2 μg/mL. Since TCI has never been used in emergency departments (ED), the brain propofol concentrations which are necessary for sedation and awakening of the patient are not known and must be determined experimentally.
In this single-center, prospective, interventional study, safety and feasibility of TCI will be studied in an ED with the primary objective of determining the brain propofol concentrations necessary to reach the an optimal sedation in for patients with indications ofsustaining very painful orthopedic emergency emergent procedures. As secondary objectives, we will study the characteristics of sedations obtained (level, delays, lengths); the Delays, lengths and levels of sedation obtained, overall delivered doses of propofol administered; the , nature, appearance delays and lengths of potential adverse events (AE) related to procedural sedation, particularly complications related to procedural sedation, and necessary interventions necessary to handle these AE., will be studied as secondary objectives
- Conditions
- Joint Dislocation, Limb Fracture
- Being tested
- Target control infusion with propofol
- Keywords
- ED, dislocation reduction, emergency department, TCI, Target-controlled infusion, sedation, fracture reduction
- Medical subject headings
- Joint Dislocations, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Target control infusion with propofolDrug
Target control infusion with propofol for patients with indications of sustaining very painful orthopedic emergency emergent procedures
| Study group | Role | What they receive |
|---|---|---|
| Target-controlled infusion (TCI) | Experimental | Target-controlled infusion (TCI) with propofol up to 5.5µg/ml during an anticipated average maximal time of 15 minutes Receives: Drug: Target control infusion with propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propofol brain concentration
Propofol brain concentration necessary for the patient to reach a Ramsay score of 5 (optimal sedation) (Ce_Ramsay5)
Measured: Between the beginning of sedation (T0) and the beginning of the orthopedic procedure (T_Ramsay5)
Secondary outcomes (2)
Delay between the beginning of sedation (T0) and the beginning of the orthopedic procedure (T_Ramsay5)
the delay is the outcome, T_Ramsay5 (up to an anticipated average maximal time of 15 minutes after T0)]
Measured: the delay is the outcome, T_Ramsay5 (up to an anticipated average maximal time of 15 minutes after T0)]
Propofol brain concentration when the patient spontaneously reopen his eyes (Ce_OuvertureYeux)
Propofol brain concentration when the patient spontaneously reopen his eyes after the orthopedic procedure has been realized, the TCI syringe been switched off, and the immobilization been placed (Ce_OuvertureYeux)
Measured: Time after T0 when the patient spontaneously reopen his eyes (up to an anticipated average maximal time of 30 minutes after T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2018
- Study start9 May 2019
- Primary completion25 Oct 2020
- Study completion25 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Joint DislocationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabien LEMOEL, PhD, Principal investigator, Emergency Department, Universitary Hospital of Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783494
- Sponsor's protocol ID
- 18-PP-04
- Acronym
- SIVOC
- Status last verified
- Mar 2026
- First submitted
- 19 Dec 2018
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lemoel F, Lemachatti A, Occelli C, Levraut J, Contenti J. Target-controlled infusion for emergency department procedural sedation: influence of age on required propofol concentration targets. Eur J Emerg Med. 2025 Jun 1;32(3):210-212. doi: 10.1097/MEJ.0000000000001220. Epub 2025 Apr 28. No abstract available.
PubMed 40315032
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target-controlled Infusion With Propofol in the Emergency Department : a Prospective Study on 45 Adult Patients
- ClinicalTrials.gov ID
- NCT03783494
- Acronym / sponsor ID
- SIVOC / 18-PP-04
- Conditions
- Joint Dislocation, Limb Fracture
- Keywords
- ED, dislocation reduction, emergency department, TCI, Target-controlled infusion, sedation, fracture reduction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 9 May 2019 (actual)
- Primary completion
- 25 Oct 2020 (actual)
- Study completion
- 25 Oct 2020 (actual)
- First posted
- 21 Dec 2018 (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.
Procedural sedation is an emergency medicine technique that provides a brief, deep sedation in order to perform very painful emergency emergent procedures such as displaced fracture or dislocated joints reduction. Propofol is recommended for this purpose, injected administered in slow IV bolus injections according to the technique known as manual titration. But despite this precaution, temporarily excessive sedation can happen, and a side effect can appear (arterial hypotension or respiratory depression). Target-controlled infusion (TCI) is an anesthesia technique that permits to obtain a precise constant and stable concentration of medication, boluses volumes of injection being calculated and delivered automatically by an electric syringe equipped with a software obedient to existing pharmacokinetic models. In the operating room, Ffor anesthetic induction, maintenance and awakening, respectively, in the operating room, the brain concentrations of propofol range respectively from 2 to 6 μg/mL, 2 to 4 μg/mL, and between 0.8 and 1.2 μg/mL, respectively. Since TCI has never been used in emergency departments (ED), the brain propofol concentrations which are necessary for sedation and awakening of the patient are not known and must be determined experimentally.
In this single-center, prospective, interventional study, safety and feasibility of TCI will be studied in one ED with the primary objective of determining the brain propofol concentrations necessary to reach the an optimal sedation in for patients with indications of sustaining very painful orthopedic emergency emergent procedures
Detailed description
Procedural sedation is an emergency medicine technique that provides a brief, deep sedation in order to perform very painful emergency emergent procedures such as displaced fracture or dislocated joints reduction. For this purpose, propofol is a remarkable sedative agent for its very short elimination half-life, antiemetic property and myorelaxant effects. It is recommended to inject administer it in slow IV boluses injections according to the technique known as manual titration, but despite this precaution, temporarily excessive sedation can happen, and a side effect appear (arterial hypotension or respiratory depression).
Target-controlled infusion (TCI) is an anesthesia technique that permits to obtain a precise constant and stable concentration of medication, boluses volumes of injection being calculated and delivered automatically by an electric syringe equipped with a software obedient to existing pharmacokinetic models.
The age, size and weight of the patient are filledentered, then the syringe delivers the volume which is necessary and sufficient to reach and maintain the target concentration chosen by the practitioner. For anesthetic induction in the operating room, the brain concentrations of propofol used range from 2 to 6 μg/mL, then the general anesthesia maintenance is obtained with 2 to 4 μg/mL, and the patient awakening usually happens between 0.8 and 1.2 μg/mL. Since TCI has never been used in emergency departments (ED), the brain propofol concentrations which are necessary for sedation and awakening of the patient are not known and must be determined experimentally.
In this single-center, prospective, interventional study, safety and feasibility of TCI will be studied in an ED with the primary objective of determining the brain propofol concentrations necessary to reach the an optimal sedation in for patients with indications ofsustaining very painful orthopedic emergency emergent procedures. As secondary objectives, we will study the characteristics of sedations obtained (level, delays, lengths); the Delays, lengths and levels of sedation obtained, overall delivered doses of propofol administered; the , nature, appearance delays and lengths of potential adverse events (AE) related to procedural sedation, particularly complications related to procedural sedation, and necessary interventions necessary to handle these AE., will be studied as secondary objectives
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Target-controlled infusion (TCI) | Experimental | Drug: Target control infusion with propofolTarget-controlled infusion (TCI) with propofol up to 5.5µg/ml during an anticipated average maximal time of 15 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 :
- Signed free informed consent or inclusion in the context of an emergency situation
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Target control infusion with propofolTarget control infusion with propofol for patients with indications of sustaining very painful orthopedic emergency emergent procedures | Drug | Target-controlled infusion (TCI) |
Primary outcome
Propofol brain concentration
Time frame: Between the beginning of sedation (T0) and the beginning of the orthopedic procedure (T_Ramsay5)
Propofol brain concentration necessary for the patient to reach a Ramsay score of 5 (optimal sedation) (Ce_Ramsay5)
2 secondary outcomes
Delay between the beginning of sedation (T0) and the beginning of the orthopedic procedure (T_Ramsay5)
Time frame: the delay is the outcome, T_Ramsay5 (up to an anticipated average maximal time of 15 minutes after T0)]
Propofol brain concentration when the patient spontaneously reopen his eyes (Ce_OuvertureYeux)
Time frame: Time after T0 when the patient spontaneously reopen his eyes (up to an anticipated average maximal time of 30 minutes after T0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Results publication: PubMed 40315032Lemoel F, Lemachatti A, Occelli C, Levraut J, Contenti J. Target-controlled infusion for emergency department procedural sedation: influence of age on required propofol concentration targets. Eur J Emerg Med. 2025 Jun 1;32(3):210-212. doi: 10.1097/MEJ.0000000000001220. Epub 2025 Apr 28. No abstract available.
- Individual participant dataSharing planned: No
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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.
Fabien LEMOEL, PhD principal investigator
Emergency Department, Universitary Hospital of Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Joint Dislocation and Limb Fracture, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 8 inclusion and 13 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: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propofol brain concentration (time frame: Between the beginning of sedation (T0) and the beginning of the orthopedic procedure (T_Ramsay5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03783494, which also lists 1 linked publication.
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 24 Mar 2026.