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Intraoperative Bleeding During Endoscopic Sinus Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01014728
First Posted: November 17, 2009
Last Update Posted: February 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Chicago
Results First Submitted: November 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
No text entered.

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 
Overall Participants Analyzed 
[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



Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01014728     History of Changes
Other Study ID Numbers: 09-317A
First Submitted: November 13, 2009
First Posted: November 17, 2009
Results First Submitted: November 20, 2013
Results First Posted: January 9, 2014
Last Update Posted: February 14, 2014