Back to resultsIntraoperative Bleeding During Endoscopic Sinus Surgery
Primary Purpose
Blood Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
propofol
sevoflurane
Sponsored by
About this trial
This is an interventional treatment trial for Blood Loss
Eligibility Criteria
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
Sites / Locations
- The University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intravenous anesthesia
Inhalation anesthesia
Arm Description
Intravenous anesthesia with propofol for endoscopic sinus surgery
Inhalation anesthesia with sevoflurane for endoscopic sinus surgery
Outcomes
Primary Outcome Measures
Estimated Blood Loss
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
Anesthesiologist Numeric Rating Scale (ANRS)
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)
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.
Full Information
NCT ID
NCT01014728
First Posted
November 13, 2009
Last Updated
January 21, 2014
Sponsor
University of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT01014728
Brief Title
Intraoperative Bleeding During Endoscopic Sinus Surgery
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 Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravenous anesthesia
Arm Type
Active Comparator
Arm Description
Intravenous anesthesia with propofol for endoscopic sinus surgery
Arm Title
Inhalation anesthesia
Arm Type
Active Comparator
Arm Description
Inhalation anesthesia with sevoflurane for endoscopic sinus surgery
Intervention Type
Drug
Intervention Name(s)
propofol
Intervention Description
100-200mcg/kg/min by infusion
Intervention Type
Drug
Intervention Name(s)
sevoflurane
Intervention Description
1-3% of sevoflurane (expired)
Primary Outcome Measure Information:
Title
Estimated Blood Loss
Description
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.
Time Frame
from the start of surgery to the end of surgery, up to 6 hours
Secondary Outcome Measure Information:
Title
Anesthesiologist Numeric Rating Scale (ANRS)
Description
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).
Time Frame
at the end of surgery (up to 6 hours)
Title
Surgeon's Numeric Rating Scale (SNRS)
Description
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.
Time Frame
at the end of surgery (up to 6 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert M Naclerio, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Intraoperative Bleeding During Endoscopic Sinus Surgery
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