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Clinical Trials/EUCTR2018-004300-19-FR
EUCTR2018-004300-19-FR
Active, not recruiting
Phase 1

Target-controled infusion with propofol in the Emergency Department : a prospective study on 50 adult patients - SIVOC

CHU DE NICE0 sites50 target enrollmentDecember 14, 2018
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ConditionsJoint dislocationLimb displaced fractureMedDRA version: 20.0 Level: HLT Classification code 10075886 Term: Limb fractures and dislocations System Organ Class: 100000004863Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Drugspropofol

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Joint dislocation
Sponsor
CHU DE NICE
Enrollment
50
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 14, 2018
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

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 a patient with an orthopedic lesion requiring a potentially painful emergency therapeutic action (reduction of a joint dislocation or realignment of a limb displaced fracture)
  • •Signed free informed consent or inclusion in the context of an emergency situation
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 50
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 50

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, soja or peanuts
  • •ASA comorbidity score of 4 or more
  • •Heart, respiratory, renal or hepatic failure
  • •Lipid metabolism disorder
  • •Mitochondrial disease
  • •Hemodynamic instability, multiple traumatism
  • •Elevated intracranial tension

Outcomes

Primary Outcomes

Not specified

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