Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation

Hennepin Healthcare

Status and phase: Completed; Phase 4

Conditions: Sedation

Treatments: Drug: Propofol; Drug: Alfentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT00997126

MMRF093030

Details and patient eligibility

About

This is a clinical trial of propofol and alfentanil as agents for moderated procedural sedation in patients undergoing sedation in the emergency department (ED).

Full description

This was initially going to be a trial of propofol vs alfentanil vs nitrous oxide, but our use of nitrous oxide was discontinued before the trial began and the trial was conducted with only two arms

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults undergoing moderate procedural sedation in the Emergency Department

Exclusion criteria

• Age <18 years
• Pregnancy
• Intoxication
• Cannot give informed consent
• Allergy to any of the three study medications
• ASA physical status score > 2
• Patients who require deep procedural sedation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Propofol

Active Comparator group

Description:

Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation

Treatment:

Drug: Propofol

Alfentanil

Active Comparator group

Description:

Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation

Treatment:

Drug: Alfentanil