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Intraoperative Bleeding During Endoscopic Sinus Surgery

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. Identifier: NCT01014728
Recruitment Status : Completed
First Posted : November 17, 2009
Results First Posted : January 9, 2014
Last Update Posted : February 14, 2014
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
The purpose of this study is to compare the blood loss during sinus surgery looking at two different types of anesthesia: either intravenous anesthesia with propofol or inhalational anesthesia with sevoflurane.

Condition or disease Intervention/treatment Phase
Blood Loss Drug: propofol Drug: sevoflurane Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Intraoperative Bleeding During Endoscopic Sinus Surgery Between Patients Receiving Total Intravenous Anesthesia With Propofol and Patients Receiving an Inhalational Anesthetic With Sevoflurane
Study Start Date : November 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: Intravenous anesthesia
Intravenous anesthesia with propofol for endoscopic sinus surgery
Drug: propofol
100-200mcg/kg/min by infusion

Active Comparator: Inhalation anesthesia
Inhalation anesthesia with sevoflurane for endoscopic sinus surgery
Drug: sevoflurane
1-3% of sevoflurane (expired)

Primary Outcome Measures :
  1. Estimated Blood Loss [ Time Frame: from the start of surgery to the end of surgery, up to 6 hours ]
    Estimated blood loss in milliliters per hour is calculated by subtracting the volume of total irrigation used during the case from the total amount of fluid in the suction canister at the end of surgery and dividing by surgical time in hours.

Secondary Outcome Measures :
  1. Anesthesiologist Numeric Rating Scale (ANRS) [ Time Frame: at the end of surgery (up to 6 hours) ]
    The anesthesiologist numeric rating scale is to rate the ease of the anesthesia technique ranging from 0 to 10 (10 is best, 0 is worst).

  2. Surgeon's Numeric Rating Scale (SNRS) [ Time Frame: at the end of surgery (up to 6 hours) ]
    The surgeon's numeric rating scale(SNRS)is to rate the surgical conditions (mucosal bleeding and visibility) on a scale ranging from 0 to 10, with 0 defined as cadaveric conditions and 10 as severe bleeding requiring constant suction.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • male or female patients who are 18 years of age or older,
  • ASA grade 1 (normal otherwise healthy patient),
  • ASA grade 2 (patient with mild systemic disease),
  • patients who have chronic sinusitis with or without nasal polyps.

Exclusion Criteria:

  • pregnancy,
  • abnormal coagulation panel
  • preoperative use of NSAIDS or ASA medications within 7 days,
  • end-stage renal disease,
  • allergy to any of the used medications,
  • maximal body mass index over 35

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01014728

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United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
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Principal Investigator: Robert M Naclerio, MD University of Chicago

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Responsible Party: University of Chicago Identifier: NCT01014728     History of Changes
Other Study ID Numbers: 09-317A
First Posted: November 17, 2009    Key Record Dates
Results First Posted: January 9, 2014
Last Update Posted: February 14, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
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Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation