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Target-controlled Infusion With Propofol in the Emergency Department : a Prospective Study on 45 Adult Patients (SIVOC)

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ClinicalTrials.gov Identifier: NCT03783494
Recruitment Status : Recruiting
First Posted : December 21, 2018
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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 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


Condition or disease Intervention/treatment Phase
Joint Dislocation Limb Fracture Drug: Target control infusion with propofol Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Target-controlled Infusion With Propofol in the Emergency Department : a Prospective Study on 45 Adult Patients
Actual Study Start Date : April 10, 2019
Actual Primary Completion Date : April 10, 2019
Estimated Study Completion Date : April 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dislocations
Drug Information available for: Propofol

Arm Intervention/treatment
Experimental: Target-controlled infusion (TCI)
Target-controlled infusion (TCI) with propofol up to 5.5µg/ml during an anticipated average maximal time of 15 minutes
Drug: Target control infusion with propofol
Target control infusion with propofol for patients with indications of sustaining very painful orthopedic emergency emergent procedures




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)] ]
    the delay is the outcome, T_Ramsay5 (up to an anticipated average maximal time of 15 minutes after T0)]

  2. 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) ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03783494


Contacts
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Contact: Fabien LEMOEL, PhD 0492038535 ext 0033 lemoel.f@chu-nice.fr
Contact: Jocelyn RAPP 0492038535 ext 0033 rapp.j@chu-nice.fr

Locations
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France
Emergency Department Recruiting
Nice, France, 06000
Contact: Delphine DEL CONT, PM       delcont.d@chu-nice.fr   
Principal Investigator: Fabien LEMOEL, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
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Principal Investigator: Fabien LEMOEL, PhD Emergency Department, Universitary Hospital of Nice
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT03783494    
Other Study ID Numbers: 18-PP-04
First Posted: December 21, 2018    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Nice:
ED
dislocation reduction
emergency department
TCI
Target-controlled infusion
sedation
fracture reduction
Additional relevant MeSH terms:
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Joint Dislocations
Emergencies
Wounds and Injuries
Disease Attributes
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics