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A Safety Study of AQUAVAN® (Fospropofol Disodium) Injection for Sedation During Minor Surgical Procedures.

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00327392
First received: May 16, 2006
Last updated: May 17, 2012
Last verified: May 2012
Results First Received: March 1, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Procedural Sedation
Intervention: Drug: AQUAVAN® (fospropofol disodium) Injection

  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
This study recruited at 12 study centers in the US during the period of 22-Jun-2006 to 01 Mar 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subjects received fentanyl at an initial dose of 50 μg as an analgesic pretreatment 5 minutes prior to the administration of the initial dose of fospropofol disodium (also referred to as LUSEDRA and formerly known as AQUAVAN). After fentanyl administration, the venous catheter was flushed with 2 mL of sterile saline solution.

Reporting Groups
  Description
Fospropofol Disodium Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.

Participant Flow:   Overall Study
    Fospropofol Disodium  
STARTED     123  
COMPLETED     123  
NOT COMPLETED     0  



  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
Fospropofol Disodium Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.

Baseline Measures
    Fospropofol Disodium  
Number of Participants  
[units: participants]
  123  
Age  
[units: years]
Mean ± Standard Deviation
  51.3  ± 15.3  
Gender  
[units: participants]
 
Female     67  
Male     56  
Race/Ethnicity, Customized  
[units: particpants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     9  
White     109  
More than one race     0  
Unknown or Not Reported     0  
Hispanic/Latino     3  
Other     1  
Weight (kg)  
[units: participants]
 
<60     18  
>60 to <90     69  
>90     36  
American Society of Anesthesiologists (ASA) status  
[units: participants]
 
P1 ( A normal healthy patient )     33  
P2 ( A patient with mild systemic disease )     67  
P3 ( A patient with severe systemic disease )     22  
P4 (High risk, severely compromised by disease)     1  



  Outcome Measures

1.  Primary:   Incidence of Airway Assistance in Patients Undergoing Minor Surgical Procedures   [ Time Frame: 2 hours ]


  Serious Adverse Events


  Other Adverse Events


  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
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  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: Eisai Medical Services
Organization: Eisai Inc
phone: 1-888-422-4743


No publications provided


ClinicalTrials.gov Identifier: NCT00327392     History of Changes
Other Study ID Numbers: 3000-0523
Study First Received: May 16, 2006
Results First Received: March 1, 2012
Last Updated: May 17, 2012
Health Authority: United States: Food and Drug Administration