Status:
COMPLETED
Target-controlled Infusion With Propofol in the Emergency Department : a Prospective Study on 45 Adult Patients
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Joint Dislocation
Limb Fracture
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 join...
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 join...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2020
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03783494
Start Date
May 9 2019
End Date
October 25 2020
Last Update
November 18 2023
Active Locations (1)
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1
Emergency Department
Nice, France, 06000