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

• Status: Unknown status
• Trial end date: 2020-04-10
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Nice
• Treatments: Propofol

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