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

Fractures Reduction Clinical Trial

— MEMOPROPO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02200744
• Other study ID #: 2013/CHU/08
• Secondary ID: 2013-003669-32
• Status: Recruiting
• Phase: N/A
• First received: July 24, 2014
• Last updated: February 3, 2015
• Start date: April 2014
• Est. completion date: April 2017

Study information

• Verified date: February 2015
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: Xavier Combes, MD
• Phone: 02 62 90 60 70
• Email: x.combes.samu974[@]chu-reunion.fr
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertésFrance: Ministry of Health
• Study type: Observational

Clinical Trial 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 .

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: April 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dislocations
• Emergencies
• Fractures Reduction
• Joint Dislocation Reduction

Locations

Country	Name	City	State
France	Groupe Hospitalier Est Réunion	Saint Benoît	La Réunion
France	CHU de la Réunion	Saint Denis	La Réunion
France	Centre Hospitalier Gabriel Martin	Saint Paul	La Réunion
France	CHU de La Réunion	Saint Pierre	La Réunion

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recall incidence	questionnaire of Brice amended by Sandin	At 2 hours (+/- 15 minutes) after procedural sedation with propofol	No
Secondary	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	About 24 hours after procedural sedation with propofol	No
Secondary	Patient's satisfaction assessment	numerical verbal scale	At 2 hours (+/- 15 minutes) after procedural sedation with propofol	No