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

C

Centre Hospitalier Universitaire de la Réunion

Status

Unknown

Conditions

Fractures Reduction
Joint Dislocation Reduction

Study type

Observational

Funder types

Other

Identifiers

NCT02200744
2013-003669-32 (Other Identifier)
2013/CHU/08

Details and patient eligibility

About

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 .

Full 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).

Enrollment

250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

250 participants in 1 patient group

Dislocation reduction using propofol

Trial contacts and locations

4

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Central trial contact

Xavier Combes, MD

Data sourced from clinicaltrials.gov

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