Intraoperative Bleeding During Endoscopic Sinus Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01014728
First received: November 13, 2009
Last updated: January 21, 2014
Last verified: January 2014
Results First Received: November 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Blood Loss
Interventions: Drug: propofol
Drug: sevoflurane

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intravenous Anesthesia After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
Inhalation Anesthesia After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.

Participant Flow:   Overall Study
    Intravenous Anesthesia     Inhalation Anesthesia  
STARTED     18     15  
COMPLETED     18     15  
NOT COMPLETED     0     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.
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Reporting Groups
  Description
Intravenous Anesthesia After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
Inhalation Anesthesia After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
Total Total of all reporting groups

Baseline Measures
    Intravenous Anesthesia     Inhalation Anesthesia     Total  
Number of Participants  
[units: participants]
  18     15     33  
Age  
[units: years]
Mean ± Standard Deviation
  41.3  ± 16.9     43.4  ± 16.6     42.3  ± 16.5  
Gender  
[units: participants]
     
Female     9     7     16  
Male     9     8     17  



  Outcome Measures
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1.  Primary:   Estimated Blood Loss   [ Time Frame: from the start of surgery to the end of surgery, up to 6 hours ]

2.  Secondary:   Anesthesiologist Numeric Rating Scale (ANRS)   [ Time Frame: at the end of surgery (up to 6 hours) ]

3.  Secondary:   Surgeon’s Numeric Rating Scale (SNRS)   [ Time Frame: at the end of surgery (up to 6 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: Dr. Robert Naclerio
Organization: University of Chicago
phone: 773-702-0080
e-mail: rnacleri@surgery.bsd.uchicago.edu


No publications provided


Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01014728     History of Changes
Other Study ID Numbers: 09-317A
Study First Received: November 13, 2009
Results First Received: November 20, 2013
Last Updated: January 21, 2014
Health Authority: United States: Institutional Review Board