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

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 .

Study Overview

• Status: Unknown
• Conditions: Fractures Reduction; Joint Dislocation Reduction

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).

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• France
  • La Réunion
    • Saint Benoît, La Réunion, France, 97470
      • Recruiting
      • Groupe Hospitalier Est Réunion
      • Contact: Marc Weber, MD
      • Principal Investigator: Marc Weber, Md
    • Saint Denis, La Réunion, France, 97400
      • Recruiting
      • Chu de La Reunion
      • Contact: Xavier Combes, MD; Phone Number: 02 62 90 60 70; Email: x.combes.samu974@chu-reunion.fr
      • Principal Investigator: Xavier Combes, MD
    • Saint Paul, La Réunion, France, 97460
      • Recruiting
      • Centre Hospitalier Gabriel Martin
      • Contact: Ophelie Pierotti, MD; Phone Number: 0692702330; Email: opierotti222@hotmail.com
      • Principal Investigator: Ophelie Pierotti, MD
    • Saint Pierre, La Réunion, France, 97448
      • Not yet recruiting
      • Chu de La Reunion
      • Contact: Pierre-Jean Marianne, MD; Phone Number: 02 62 71 98 57; Email: pierre-jean.marianne-cassou@chu-reunion.fr
      • Principal Investigator: Pierre-Jean Marianne, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults patients managed in emergency department with a procedural sedation protocol using propofol

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Dislocation reduction using propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recall incidence	questionnaire of Brice amended by Sandin	At 2 hours (+/- 15 minutes) after procedural sedation with propofol

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Patient's satisfaction assessment	numerical verbal scale	At 2 hours (+/- 15 minutes) after procedural sedation with propofol

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion
• Investigators: Principal Investigator: Pierre-Jean Marianne, MD, Chu de La Reunion; Principal Investigator: Marc Weber, MD, Groupe Hospitalier Est Réunion; Principal Investigator: Katia Mougin, MD, Centre Hospitalier Gabriel Martin

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): April 1, 2017

Study Registration Dates

• First Submitted: July 24, 2014
• First Submitted That Met QC Criteria: July 24, 2014
• First Posted (Estimate): July 25, 2014

Study Record Updates

• Last Update Posted (Estimate): February 4, 2015
• Last Update Submitted That Met QC Criteria: February 3, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: emergency department; propofol; adults; Procedural sedation; recall assessment
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Emergencies; Joint Dislocations
• Other Study ID Numbers: 2013/CHU/08; 2013-003669-32 (Other Identifier: Agence National de Sécurité du Médicament)