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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

November 13, 2009
January 21, 2014
November 2009
March 2012   (final data collection date for primary outcome measure)
Estimated Blood Loss [ Time Frame: from the start of surgery to the end of surgery, up to 6 hours ] [ Designated as safety issue: No ]
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.
estimated blood loss [ Time Frame: 60 minutes after start of surgery ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01014728 on ClinicalTrials.gov Archive Site
  • Anesthesiologist Numeric Rating Scale (ANRS) [ Time Frame: at the end of surgery (up to 6 hours) ] [ Designated as safety issue: No ]
    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).
  • Surgeon's Numeric Rating Scale (SNRS) [ Time Frame: at the end of surgery (up to 6 hours) ] [ Designated as safety issue: No ]
    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.
platelet function assay (PFA)-100 [ Time Frame: at start of surgery and 60 minutes after start ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Intraoperative Bleeding During Endoscopic Sinus Surgery
Comparison of Intraoperative Bleeding During Endoscopic Sinus Surgery Between Patients Receiving Total Intravenous Anesthesia With Propofol and Patients Receiving an Inhalational Anesthetic With Sevoflurane

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Blood Loss
  • Drug: propofol
    100-200mcg/kg/min by infusion
  • Drug: sevoflurane
    1-3% of sevoflurane (expired)
  • Active Comparator: Intravenous anesthesia
    Intravenous anesthesia with propofol for endoscopic sinus surgery
    Intervention: Drug: propofol
  • Active Comparator: Inhalation anesthesia
    Inhalation anesthesia with sevoflurane for endoscopic sinus surgery
    Intervention: Drug: sevoflurane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
June 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01014728
09-317A
No
University of Chicago
University of Chicago
Not Provided
Principal Investigator: Robert M Naclerio, MD University of Chicago
University of Chicago
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP