Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation

Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997126
• Other study ID #: MMRF093030
• Status: Completed
• Phase: Phase 4
• First received: October 12, 2009
• Last updated: December 22, 2015
• Start date: October 2009
• Est. completion date: April 2015

Study information

• Verified date: December 2015
• Source: Minneapolis Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sedation

Intervention

Drug:
• Propofol
Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation
• Alfentanil
Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation
• Nitrous Oxide
Nitrous oxide 30% inhaled, titrated to 70% prn sedation

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Medical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sub-clinical respiratory depression and clinical events associated with respiratory depression		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)	Yes
Secondary	Time to return of baseline mental status		Single time point after completion of sedation procedure	No
Secondary	Depth of sedation		Single measurement during sedation procedure	Yes
Secondary	Patient reported pain		Single measurement immediately after patient returns to baseline mental status after sedation procedure	No
Secondary	Patient reported recall of the procedure		Single measurement immediately after patient returns to baseline mental status after sedation procedure	No