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Propofol Versus Alfentanil Versus Nitrous Oxide for Moderate Procedural Sedation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00997126
First received: October 12, 2009
Last updated: December 1, 2016
Last verified: December 2016

October 12, 2009
December 1, 2016
October 2009
April 2015   (Final data collection date for primary outcome measure)
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) ]
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) ]
Complete list of historical versions of study NCT00997126 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
  • Patient Reported Pain [ Time Frame: Single measurement immediately after patient returns to baseline mental status after sedation procedure ]
  • Patient Reported Recall of the Procedure [ Time Frame: Single measurement immediately after patient returns to baseline mental status after sedation procedure ]
  • Time to return of baseline mental status [ Time Frame: Single time point after completion of sedation procedure ]
  • Depth of sedation [ Time Frame: Single measurement during sedation procedure ]
  • Patient Reported Pain [ Time Frame: Single measurement immediately after patient returns to baseline mental status after sedation procedure ]
  • Patient Reported Recall of the Procedure [ Time Frame: Single measurement immediately after patient returns to baseline mental status after sedation procedure ]
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 and alfentanil as agents for moderated procedural sedation in patients undergoing sedation in the emergency department (ED).
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
Interventional
Phase 4
Allocation: Randomized
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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
April 2015
April 2015   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00997126
MMRF093030
Yes
Not Provided
Not Provided
Not Provided
Minneapolis Medical Research Foundation
Minneapolis Medical Research Foundation
Not Provided
Principal Investigator: James R Miner, MD Minneapolis Medical Research Foundation
Minneapolis Medical Research Foundation
December 2016

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