Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT03783494
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03783494
Study Brief:
Protocol Section:
NCT03783494