Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation

Phase 4

Completed

• Conditions: Sedation
• Interventions: Drug: Alfentanil; Drug: Propofol

• Registration Number: NCT00997126
• Lead Sponsor: Hennepin Healthcare Research Institute

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-12
• Study First Submitted QC: 2009-10-16
• Study First Posted: 2009-10-19
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Results First Submitted: 2016-09-12
• Status Verified: 2016-12
• Results First Submitted QC: 2016-12-01
• Last Update Submitted: 2016-12-01
• Results First Posted: 2017-01-27
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alfentanil	Alfentanil	Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation
Propofol	Propofol	Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation

Primary Outcome Measures

Name	Time	Method
Number of Participants With Sub-clinical Respiratory Depression and Clinical Events Associated With Respiratory Depression During the Sedation Procedure	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 Outcome Measures

Name	Time	Method
Depth of Sedation Measured Using the OAAS Scale	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
Patient Reported Pain	Single measurement immediately after patient returns to baseline mental status after sedation procedure
Patient Reported Recall of the Procedure	Single measurement immediately after patient returns to baseline mental status after sedation procedure
Time to Return of Baseline Mental Status From Start of Procedure in Minutes	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

Trial Locations

Locations (1)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States