NCT01014728CompletedNot Applicable
Comparison of Intraoperative Bleeding During Endoscopic Sinus Surgery Between Patients Receiving Total Intravenous Anesthesia With Propofol and Patients Receiving an Inhalational Anesthetic With Sevoflurane
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Chicago
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Estimated Blood Loss
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Intravenous anesthesia
Active Comparator
Intravenous anesthesia with propofol for endoscopic sinus surgery
Intervention: propofol (Drug)
Inhalation anesthesia
Active Comparator
Inhalation anesthesia with sevoflurane for endoscopic sinus surgery
Intervention: sevoflurane (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Anesthesiologist Numeric Rating Scale (ANRS)(at the end of surgery (up to 6 hours))
- Surgeon's Numeric Rating Scale (SNRS)(at the end of surgery (up to 6 hours))
Investigators
Study Sites (1)
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