- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02200744
Incidence of Recall After Procedural Sedation With Propofol in the Emergency Department (MEMOPROPO)
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
La Réunion
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Saint-Benoît, La Réunion, France, 97470
- Groupe Hospitalier Est Réunion
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Saint-Denis, La Réunion, France, 97400
- CHU de La Réunion
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Saint-Paul, La Réunion, France, 97460
- Centre Hospitalier Gabriel Martin
-
Saint-Pierre, La Réunion, France, 97448
- CHU de La Réunion
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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?
Design Details
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
Time Frame: At 2 hours (+/- 15 minutes) after procedural sedation with propofol
|
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
Time Frame: About 24 hours after procedural sedation with propofol
|
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
Time Frame: At 2 hours (+/- 15 minutes) after procedural sedation with propofol
|
numerical verbal scale
|
At 2 hours (+/- 15 minutes) after procedural sedation with propofol
|
Collaborators and Investigators
Investigators
- Principal Investigator: Pierre-Jean Marianne, MD, CHU de La Réunion
- Principal Investigator: Marc Weber, MD, Groupe Hospitalier Est Réunion
- Principal Investigator: Katia Mougin, MD, Centre Hospitalier Gabriel Martin
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013/CHU/08
- 2013-003669-32 (Other Identifier: Agence National de Sécurité du Médicament)
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