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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous anesthesia | Active Comparator | Intravenous anesthesia with propofol for endoscopic sinus surgery |
|
| Inhalation anesthesia | Active Comparator | Inhalation anesthesia with sevoflurane for endoscopic sinus surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propofol | Drug | 100-200mcg/kg/min by infusion |
| |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert M Naclerio, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous Anesthesia | After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery. |
| FG001 | Inhalation Anesthesia | After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous Anesthesia | After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery. |
| BG001 | Inhalation Anesthesia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mL/h | from the start of surgery to the end of surgery, up to 6 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravenous Anesthesia | After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Naclerio | University of Chicago | 773-702-0080 | rnacleri@surgery.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| sevoflurane |
| Drug |
1-3% of sevoflurane (expired) |
|
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) |
After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Secondary | 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). | There were three patients in the inhalation anesthesia group with missing values. | Posted | Median | Full Range | units on a scale | at the end of surgery (up to 6 hours) |
|
|
|
|
| Secondary | 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. | There were three patients in the inhalation anesthesia group with missing values. | Posted | Median | Full Range | units on a scale | at the end of surgery (up to 6 hours) |
|
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Inhalation Anesthesia | After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery. | 0 | 15 | 0 | 15 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |