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Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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