Intraoperative Bleeding During Endoscopic Sinus Surgery

Study Overview
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Brief Summary
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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.

Official Title
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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
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Blood Loss

Intervention / Treatment
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* Drug: propofol
* Drug: sevoflurane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous anesthesia<br>Intravenous anesthesia with propofol for endoscopic sinus surgery | Drug: propofol<br>* 100-200mcg/kg/min by infusion<br>|
| Active Comparator: Inhalation anesthesia<br>Inhalation anesthesia with sevoflurane for endoscopic sinus surgery | Drug: sevoflurane<br>* 1-3% of sevoflurane (expired)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | from the start of surgery to the end of surgery, up to 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | at the end of surgery (up to 6 hours) | 
| 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. | at the end of surgery (up to 6 hours) |