Incidence of Recall After Procedural Sedation With Propofol in the Emergency Department

N/AUnknownNCT02200744

Centre Hospitalier Universitaire de la Réunion250 enrolled

Overview

The purpose of this study is to determine the incidence of recall in patients managed in emergency department with a procedural sedation protocol using propofol in a population of 250 .

After procedural sedation for fracture or joint dislocation reduction using propofol, adult patients recall will be assessed with a standardised form. This recall assessment will be realised 2 hours (+/- 15 minutes) after the procedural sedation and the day after. The primary outcome measure will be the recall incidence 2 hours (+/- 15 minutes) after a procedural sedation. A secondary outcome will be the recall incidence one day after the procedural sedation. The recall will be defined by a positive answer to the third question of the Sandin form (Lancet. 2000;355(9205):707-11).

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Fractures Reduction Joint Dislocation Reduction

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults patients (\> 18 years old) who had a procedural sedation in emergency department using propofol for fracture or joint dislocation reduction * Patients who received an initial injection of Propofol by slow intravenous injection of 1 mg/kg in 20 seconds * Inclusion less than 2 hours from the injection of Propofol * Patients who have signed a consent to participate in the study * Patients covered by social security. Exclusion Criteria: * Patients under 18 years old * Patients who cannot signed the informed consent * Patients who had procedural sedation using other drugs that propofol * Participation in another study type biomedical research

Locations (4)

Groupe Hospitalier Est Réunion

Saint-Benoît, La Réunion, France

RECRUITING

CHU de la Réunion

Saint-Denis, La Réunion, France

RECRUITING

Centre Hospitalier Gabriel Martin

Saint-Paul, La Réunion, France

RECRUITING

Outcomes

Primary Outcomes

Recall incidence

questionnaire of Brice amended by Sandin

Time frame: At 2 hours (+/- 15 minutes) after procedural sedation with propofol

Secondary Outcomes

Recall incidence

The patient will be contacted by phone the next day after procedural sedation with propofol. They will answer the questionnaire of Brice amended by Sandin

Time frame: About 24 hours after procedural sedation with propofol

Patient's satisfaction assessment

numerical verbal scale

Time frame: At 2 hours (+/- 15 minutes) after procedural sedation with propofol

Central Contacts

Xavier Combes, MD

CONTACT

02 62 90 60 70 x.combes.samu974@chu-reunion.fr

Data from ClinicalTrials.gov

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