Intraoperative Bleeding During Endoscopic Sinus Surgery
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:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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|
- 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.
- 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.
|Study Start Date:||November 2009|
|Study Completion Date:||June 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Intravenous anesthesia
Intravenous anesthesia with propofol for endoscopic sinus surgery
100-200mcg/kg/min by infusion
Active Comparator: Inhalation anesthesia
Inhalation anesthesia with sevoflurane for endoscopic sinus surgery
1-3% of sevoflurane (expired)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014728
|United States, Illinois|
|The University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Robert M Naclerio, MD||University of Chicago|