Skip to main content
OpenTrials
Completed

NCT Number: NCT00997126

Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sedation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

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

alfentanil

Drug

Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation

Primary outcomes

  1. Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure

    Time frame: From one minute prior to start of procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure (~3-60 minutes depending on procedure duration)

Secondary outcomes

  1. Time to Return of Baseline Mental Status From Start of Procedure in Minutes

    Time frame: Single time point after completion of sedation procedure, measured from start of procedure until the patient returns to baseline mental status up to 24 hours

  2. Depth of Sedation Measured Using the OAAS Scale

    Time frame: Single measurement during sedation procedure

    Observers Assesment of Alertness Scale, 5 responds normally to voice, 4 lethargic response to voice, 3 responds only to loud voice or light touch, 2 responds only to mild prodding or shaking, 1 responds only to painful stimuli, 0 no response to painful stimuli

  3. Patient Reported Pain

    Time frame: Single measurement immediately after patient returns to baseline mental status after sedation procedure

  4. Patient Reported Recall of the Procedure

    Time frame: Single measurement immediately after patient returns to baseline mental status after sedation procedure

Sponsors and collaborators

Lead sponsor

Hennepin Healthcare Research Institute

Other

Registry information

Official study title

Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation in the Emergency Department

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Oct 19, 2009
Registry last updated
Jan 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.