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Utilization of total intravenous anesthesia (TIVA) has been proposed as a method to improve visualization during endoscopic sinus surgery (ESS), largely due to its physiologic decrease in cardiac output without the peripheral smooth muscle relaxation and resultant vasodilation associated with inhaled anesthetics. This may be especially important in cases of advanced inflammatory sinus disease, when visualization may be most compromised. The goal of this study is to improve clinical practice paradigms by evaluating the use of TIVA versus inhaled anesthetic for maintenance of anesthesia in ESS for advanced paranasal sinus disease.
Specific Aims:
General Design:
Double blind, randomized controlled trial of total intravenous versus inhaled anesthetic for maintenance of anesthesia during endoscopic sinus surgery.
Subject Recruitment and Screening:
Patients will be screened for study inclusion by the principal investigator (EDM) during their preoperative visit in the Department of Otolaryngology. Those meeting inclusion criteria will be introduced to the study at this time. A full description of the research purpose, personnel, procedures, risks and benefits will be presented, and a copy of the study consent documentation will be provided for home review.
Method for Assigning Subjects to Treatment Groups:
On the day of surgery, eligible participants will be admitted to the Day of Surgery Department, where a member of the Anesthesia team will review study information and confirm informed consent. A randomly assigned, sealed envelope will then be opened to assign participants to either the TIVA, or inhaled anesthetic cohort. At no time will the patient or surgeon be made aware of the patient's cohort.
Blinding of Study Drug:
At no time will the patient or surgeon be made aware of the patient's cohort. During the procedure the surgeon is blinded to the type of anesthesia by placement of a high drape at the head of the operative table. Study reviewers will be blinded to treatment arm without cohort assignment at time of review for determination of visual field score.
Study Procedures:
Participants make no clinic/hospital visits for purposes of study completion as all patient interaction limited to visits and surveys completed as part of routine clinical care. Clinic visits will include a baseline preoperative visit, and visits at 1 week, 4 weeks, and 10 weeks after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total Intravenous | Experimental | Intravenous propofol for maintenance of anesthesia |
|
| Inhaled Anesthetic | Active Comparator | Inhaled volatile anesthetic for maintenance of anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug |
| ||
| Sevoflurane |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Visual Field Assessment | Wormald Visualization Scale (validated) Grade Assessment (0-10) -Higher scores indicate worsening visualization 0 No bleeding
| Performed intraoperatively at the end of surgical case |
| Measure | Description | Time Frame |
|---|---|---|
| Sinus-related Quality of Life | Sinonasal Outcomes Test (SNOT-22) (validated)- measures sinus symptoms. Minimum 0 Maximum 110. Higher scores indicate worse sinus symptoms. | 3 months and 6 months |
| Intraoperative Blood Loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward D McCoul, MD,MPH | Ochsner Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29979837 | Derived | Brunner JP, Levy JM, Ada ML, Tipirneni KE, Barham HP, Oakley GM, Cox DR, Nossaman BD, McCoul ED. Total intravenous anesthesia improves intraoperative visualization during surgery for high-grade chronic rhinosinusitis: a double-blind randomized controlled trial. Int Forum Allergy Rhinol. 2018 Oct;8(10):1114-1122. doi: 10.1002/alr.22173. Epub 2018 Jul 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Intravenous | Intravenous propofol for maintenance of anesthesia Propofol |
| FG001 | Inhaled Anesthetic | Inhaled volatile anesthetic for maintenance of anesthesia Sevoflurane |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Intravenous | Intravenous propofol for maintenance of anesthesia Propofol |
| BG001 | Inhaled Anesthetic | Inhaled volatile anesthetic for maintenance of anesthesia Sevoflurane |
| 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 | Intraoperative Visual Field Assessment | Wormald Visualization Scale (validated) Grade Assessment (0-10) -Higher scores indicate worsening visualization 0 No bleeding
| Posted | Median | Inter-Quartile Range | units on a scale | Performed intraoperatively at the end of surgical case |
|
12 weeks
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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 | Total Intravenous | Intravenous propofol for maintenance of anesthesia Propofol |
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By limiting study inclusion to Chronic Rhinosinusitis patients with bilateral nasal polyps and preoperative Lund-Mackay scores >12, we limit the generalizability of study findings. Single-site design limits external validity.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward D McCoul, MD, MPH | Ochsner Medical Center | 504-842-4080 | edward.mccoul@ochsner.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 8, 2017 | Nov 29, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077149 | Sevoflurane |
| D007530 | Isoflurane |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
|
Amount of blood loss (milliliters) during surgery
| At time of surgery |
| Surgical Time | Total time spent in surgery (hours) | At time of surgery |
| Post-anesthesia Care Unit Recovery Time | Hours spent in post-anesthesia care unit post-operatively | Immediately following surgery (postoperative day zero) |
| Number of Patients Treated With Post-operative Anti-emetics | patients receiving medication for post-operative nausea and/or vomiting | 24 hours following surgery completion |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Inter-Quartile Range | kg/m^2 |
|
| American Society of Anesthesiologists (ASA) Physical Status | ASA I A normal healthy patient ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life ASA V A moribund patient who is not expected to survive without the operation ASA VI A declared brain-dead patient whose organs are being removed for donor purposes | Count of Participants | Participants |
|
| Disease Factors | Number | participants |
|
| Patient Assessments | Lund Mackay Score- measures sinus opacification, Min 0 Max 24. Higher score indicates more opacification. SNOT-22 Score (Sinonasal Outcome Test-22)- measures sinus symptoms. Min 0 Max 110. Higher score indicates worse symptoms. | Median | Inter-Quartile Range | units on a scale |
|
| Co-morbidities | Number | participants |
|
Intravenous propofol for maintenance of anesthesia Propofol |
| OG001 | Inhaled Anesthetic | Inhaled volatile anesthetic for maintenance of anesthesia Sevoflurane |
|
|
| Secondary | Sinus-related Quality of Life | Sinonasal Outcomes Test (SNOT-22) (validated)- measures sinus symptoms. Minimum 0 Maximum 110. Higher scores indicate worse sinus symptoms. | Posted | Median | Inter-Quartile Range | units on a scale | 3 months and 6 months |
|
|
|
| Secondary | Intraoperative Blood Loss | Amount of blood loss (milliliters) during surgery | Posted | Median | Inter-Quartile Range | mL | At time of surgery |
|
|
|
| Secondary | Surgical Time | Total time spent in surgery (hours) | Posted | Median | Inter-Quartile Range | hours | At time of surgery |
|
|
|
| Secondary | Post-anesthesia Care Unit Recovery Time | Hours spent in post-anesthesia care unit post-operatively | Posted | Median | Inter-Quartile Range | hours | Immediately following surgery (postoperative day zero) |
|
|
|
| Secondary | Number of Patients Treated With Post-operative Anti-emetics | patients receiving medication for post-operative nausea and/or vomiting | Posted | Count of Participants | Participants | 24 hours following surgery completion |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Inhaled Anesthetic | Inhaled volatile anesthetic for maintenance of anesthesia Sevoflurane | 0 | 35 | 0 | 35 | 0 | 35 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| III |
|