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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
History of Changes
Results First Received: September 12, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Sedation
Interventions: Drug: Propofol
Drug: Alfentanil

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Propofol

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

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

Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation

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

Participant Flow:   Overall Study
    Propofol   Alfentanil
STARTED   63   63 
COMPLETED   56   52 
NOT COMPLETED   7   11 
Physician Decision                7                11 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Propofol

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

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

Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation

Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation
Total Total of all reporting groups

Baseline Measures
   Propofol   Alfentanil   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 56   52   108 
Age 
[Units: Years]
Median (Full Range) 		 36 
 (18 to 64)  		 32 
 (18 to 82)  		 34 
 (18 to 82) 
Gender 
[Units: Participants]
Count of Participants 		     
Female      31  55.4%      23  44.2%      54  50.0% 
Male      25  44.6%      29  55.8%      54  50.0% 


  Outcome Measures
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1.  Primary:   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) ]
  Show Outcome Measure 1

2.  Secondary:   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 ]
  Show Outcome Measure 2

3.  Secondary:   Depth of Sedation Measured Using the OAAS Scale   [ Time Frame: Single measurement during sedation procedure ]
  Show Outcome Measure 3

4.  Secondary:   Patient Reported Pain   [ Time Frame: Single measurement immediately after patient returns to baseline mental status after sedation procedure ]
  Show Outcome Measure 4

5.  Secondary:   Patient Reported Recall of the Procedure   [ Time Frame: Single measurement immediately after patient returns to baseline mental status after sedation procedure ]
  Show Outcome Measure 5


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
our capability of administering nitrous oxide was diminished as the trial was started, and the trial was conducted using on the propofol and alfentanil arms.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: James Miner
Organization: MinneapolisMRF
phone: 6128732493
e-mail: miner015@umn.edu



Responsible Party: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT00997126     History of Changes
Other Study ID Numbers: MMRF093030
Study First Received: October 12, 2009
Results First Received: September 12, 2016
Last Updated: December 1, 2016