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

Phase 1

• Conditions: Joint dislocation; Limb displaced fracture; MedDRA version: 20.0 Level: HLT Classification code 10075886 Term: Limb fractures and dislocations System Organ Class: 100000004863; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2018-004300-19-FR
• Lead Sponsor: CHU DE NICE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-14
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 50

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
•Epilepsy
•Lipid metabolism disorder
•Mitochondrial disease
•Hemodynamic instability, multiple traumatism
•Elevated intracranial tension
•Drug or alcohol intoxication

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determine the brain concentrations necessary to reach the optimal sedation in patients with indications of very painful orthopedic emergency procedures;Primary end point(s): Propofol brain concentration necessary for the patient to reach a Ramsay score of 5 (optimal sedation) (Ce_Ramsay5);Timepoint(s) of evaluation of this end point: Between the beginning of sedation (T0) and the beginning of the orthopedic procedure (T_Ramsay5) to be determined as a secondary outcome as described below (up to an anticipated average maximal value of 15 minutes after T0);Secondary Objective: Delays, lengths and levels of sedation obtained, overall delivered doses of propofol, nature, appearance delays and lengths of potential adverse events (AE), particularly complications related to procedural sedation, and necessary interventions to handle these AE, will be studied as secondary objectives

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Delay between the beginning of sedation (T0) and the beginning of the orthopedic procedure (T_Ramsay5);Timepoint(s) of evaluation of this end point: the delay is the outcome, T_Ramsay5 (up to an anticipated average maximal time of 15 minutes after T0)]