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

NCT ID: NCT02200744

Last Updated: 2015-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-04-30

Brief Summary

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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

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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).

Conditions

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Fractures Reduction Joint Dislocation Reduction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Dislocation reduction using propofol

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre-Jean Marianne, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de La Réunion

Marc Weber, MD

Role: PRINCIPAL_INVESTIGATOR

Groupe Hospitalier Est Réunion

Katia Mougin, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Gabriel Martin

Locations

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Groupe Hospitalier Est Réunion

Saint-Benoît, La Réunion, France

Site Status RECRUITING

CHU de la Réunion

Saint-Denis, La Réunion, France

Site Status RECRUITING

Centre Hospitalier Gabriel Martin

Saint-Paul, La Réunion, France

Site Status RECRUITING

CHU de La Réunion

Saint-Pierre, La Réunion, France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Xavier Combes, MD

Role: CONTACT

02 62 90 60 70

Facility Contacts

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Marc Weber, MD

Role: primary

Xavier Combes, MD

Role: primary

02 62 90 60 70

Ophelie Pierotti, MD

Role: primary

0692702330

Pierre-Jean Marianne, MD

Role: primary

02 62 71 98 57

Other Identifiers

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2013-003669-32

Identifier Type: OTHER

Identifier Source: secondary_id

2013/CHU/08

Identifier Type: -

Identifier Source: org_study_id

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