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

NCT03783494 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-03-24

No results posted yet for this study

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

Conditions

  • Joint Dislocation
  • Limb Fracture

Interventions

DRUG

Target control infusion with propofol

Target control infusion with propofol for patients with indications of sustaining very painful orthopedic emergency emergent procedures

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

  • Fabien LEMOEL, PhD · Emergency Department, Universitary Hospital of Nice

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-09
Primary Completion
2020-10-25
Completion
2020-10-25

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03783494 on ClinicalTrials.gov