Intraoperative Bleeding During Endoscopic Sinus Surgery
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|ClinicalTrials.gov Identifier: NCT01014728|
Recruitment Status : Completed
First Posted : November 17, 2009
Results First Posted : January 9, 2014
Last Update Posted : February 14, 2014
|Condition or disease||Intervention/treatment||Phase|
|Blood Loss||Drug: propofol Drug: sevoflurane||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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)
- 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.
- 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).
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01014728
|United States, Illinois|
|The University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Robert M Naclerio, MD||University of Chicago|