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Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Minneapolis Medical Research Foundation
Sponsor:
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00997126
First received: October 12, 2009
Last updated: October 23, 2014
Last verified: October 2014

October 12, 2009
October 23, 2014
October 2009
October 2014   (final data collection date for primary outcome measure)
Sub-clinical respiratory depression and clinical events associated with respiratory depression [ 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) ] [ Designated as safety issue: Yes ]
sub clinical respiratory depression and clinical events associated with respiratory depression [ 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) ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00997126 on ClinicalTrials.gov Archive Site
  • Time to return of baseline mental status [ Time Frame: Single time point after completion of sedation procedure ] [ Designated as safety issue: No ]
  • Depth of sedation [ Time Frame: Single measurement during sedation procedure ] [ Designated as safety issue: Yes ]
  • Patient reported pain [ Time Frame: Single measurement immediately after patient returns to baseline mental status after sedation procedure ] [ Designated as safety issue: No ]
  • Patient reported recall of the procedure [ Time Frame: Single measurement immediately after patient returns to baseline mental status after sedation procedure ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation
Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation in the Emergency Department

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Sedation
  • Drug: Propofol
    Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation
  • Drug: Alfentanil
    Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation
  • Drug: Nitrous Oxide
    Nitrous oxide 30% inhaled, titrated to 70% prn sedation
  • Active Comparator: Propofol
    Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation
    Intervention: Drug: Propofol
  • Active Comparator: Alfentanil
    Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation
    Intervention: Drug: Alfentanil
  • Active Comparator: Nitrous Oxide
    Sedation with inhaled nitrous oxide
    Intervention: Drug: Nitrous Oxide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: James R Miner, MD 612-873-8791 miner015@umn.edu
United States
 
NCT00997126
MMRF093030
Yes
Minneapolis Medical Research Foundation
Minneapolis Medical Research Foundation
Not Provided
Principal Investigator: James R Miner, MD Minneapolis Medical Research Foundation
Minneapolis Medical Research Foundation
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP