Clinical trial NCT02200744: Incidence of Recall After Procedural Sedation With Propofol in the Emergency Department
Official title: Incidence of Recall After Procedural Sedation With Propofol in the Emergency Department
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fractures Reduction
Joint Dislocation Reduction
Keywords: Procedural sedation
emergency department
adults
propofol
recall assessment
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2014-07-25
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patients managed in emergency department with a procedural sedation protocol using propofol

Brief summary: 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 .

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Recall incidence
timeFrame: At 2 hours (+/- 15 minutes) after procedural sedation with propofol
Secondary outcomes:
measure: Recall incidence
timeFrame: About 24 hours after procedural sedation with propofol
measure: Patient's satisfaction assessment
timeFrame: At 2 hours (+/- 15 minutes) after procedural sedation with propofol
Other outcomes:
Locations:
city: Saint Benoît
country: France
facility: Groupe Hospitalier Est Réunion
state: La Réunion
city: Saint Denis
country: France
facility: CHU de la Réunion
state: La Réunion
city: Saint Paul
country: France
facility: Centre Hospitalier Gabriel Martin
state: La Réunion
city: Saint Pierre
country: France
facility: CHU de La Réunion
state: La Réunion
Study officials:
affiliation: CHU de La Réunion
name: Pierre-Jean Marianne, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Groupe Hospitalier Est Réunion
name: Marc Weber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Gabriel Martin
name: Katia Mougin, MD
role: PRINCIPAL_INVESTIGATOR
References: