A Phase 4 interventional study of Propofol and Sevoflurane in Advanced Chronic Rhinosinusitis, sponsored by Ochsner Health System. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-21.
Sponsored by Ochsner Health System · Phase 4, Interventional, and Treatment
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.
330 studies on the registry are indexed under Rhinosinusitis; 55 are open to participants now.
This study's enrollment of 72 is above the median of 60 across 227 interventional studies indexed under Rhinosinusitis.
Browse Rhinosinusitis studies →Ochsner Health System is the lead sponsor of 54 studies on the registry; 7 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intravenous propofol for maintenance of anesthesia
Drug: Propofol
Inhaled volatile anesthetic for maintenance of anesthesia
Drug: Sevoflurane
Also known as: Isoflurane
Intraoperative Visual Field Assessment
Wormald Visualization Scale (validated) Grade Assessment (0-10) -Higher scores indicate worsening visualization 0 No bleeding 1. 1-2 points of ooze 2. 3-4 points of ooze 3. 5-6 points of ooze 4. 7-8 points of ooze 5. 9-10 points of ooze (sphenoid fills in 60 seconds)\* 6. 10 points of ooze, obscuring surface (sphenoid fills in 50 seconds)\* 7. Mild bleeding/oozing from entire surgical surface with slow accumulation of blood in the post nasal space (sphenoid fills by 40 seconds) 8. Moderate bleeding from entire surgical surface with moderate accumulation of blood in the post nasal space at (sphenoid fills by 30 seconds) 9. Moderately severe bleeding with rapid accumulation of blood in the post nasal space (sphenoid fills by 20 seconds) 10. Severe bleeding with nasal cavity filling rapidly(sphenoid fills in10 seconds)
Time frame: Performed intraoperatively at the end of surgical case
Sinus-related Quality of Life
Sinonasal Outcomes Test (SNOT-22) (validated)- measures sinus symptoms. Minimum 0 Maximum 110. Higher scores indicate worse sinus symptoms.
Time frame: 3 months and 6 months
Intraoperative Blood Loss
Amount of blood loss (milliliters) during surgery
Time frame: At time of surgery
Surgical Time
Total time spent in surgery (hours)
Time frame: At time of surgery
Post-anesthesia Care Unit Recovery Time
Hours spent in post-anesthesia care unit post-operatively
Time frame: 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
Time frame: 24 hours following surgery completion
| Milestone | Total Intravenous | Inhaled Anesthetic |
|---|---|---|
| Started | 37 | 35 |
| Completed | 37 | 33 |
| Not completed | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Unplanned unilateral procedure | 0 | 1 |
Wormald Visualization Scale (validated) Grade Assessment (0-10) -Higher scores indicate worsening visualization 0 No bleeding 1. 1-2 points of ooze 2. 3-4 points of ooze 3. 5-6 points of ooze 4. 7-8 points of ooze 5. 9-10 points of ooze (sphenoid fills in 60 seconds)\* 6. 10 points of ooze, obscuring surface (sphenoid fills in 50 seconds)\* 7. Mild bleeding/oozing from entire surgical surface with slow accumulation of blood in the post nasal space (sphenoid fills by 40 seconds) 8. Moderate bleeding from entire surgical surface with moderate accumulation of blood in the post nasal space at (sphenoid fills by 30 seconds) 9. Moderately severe bleeding with rapid accumulation of blood in the post nasal space (sphenoid fills by 20 seconds) 10. Severe bleeding with nasal cavity filling rapidly(sphenoid fills in10 seconds)
| units on a scale | Total Intravenous | Inhaled Anesthetic |
|---|---|---|
| Right Frontal | 3.3 (2.0 to 4.3) | 4.3 (2.8 to 5.6) |
| Right Ethmoid | 3.3 (2.1 to 4.3) | 4.2 (3.3 to 5.9) |
| Right Sphenoethmoidal Recess | 3.3 (2.7 to 4.3) | 4.8 (3.7 to 6.3) |
| Right Choana | 2.7 (2.3 to 3.3) | 3.3 (2.2 to 5.0) |
| Left Frontal | 3.3 (2.7 to 4.8) | 4.0 (3.3 to 5.3) |
| Left Ethmoid | 3.3 (2.7 to 4.3) | 4.3 (3.3 to 6.3) |
| Left Sphenoethmoidal Recess | 3.3 (2.3 to 4.3) | 4.3 (3.0 to 6.7) |
| Left Choana | 3.0 (2.3 to 3.7) | 3.7 (2.7 to 5.0) |
Sinonasal Outcomes Test (SNOT-22) (validated)- measures sinus symptoms. Minimum 0 Maximum 110. Higher scores indicate worse sinus symptoms.
| units on a scale | Total Intravenous | Inhaled Anesthetic |
|---|---|---|
| 3 months | 20.1 (12.6 to 27.6) | 14.2 (6.4 to 22.0) |
| 6 months | 21.5 (10.0 to 33.0) | 15.2 (5.9 to 24.6) |
Amount of blood loss (milliliters) during surgery
| mL | Total Intravenous | Inhaled Anesthetic |
|---|---|---|
| Intraoperative Blood Loss | 200 (100 to 450) | 300 (200 to 500) |
Total time spent in surgery (hours)
| hours | Total Intravenous | Inhaled Anesthetic |
|---|---|---|
| Surgical Time | 3.4 (2.9 to 3.9) | 3.4 (2.8 to 4.0) |
Hours spent in post-anesthesia care unit post-operatively
| hours | Total Intravenous | Inhaled Anesthetic |
|---|---|---|
| Post-anesthesia Care Unit Recovery Time | 1.3 (1.0 to 1.6) | 1.7 (1.2 to 2.5) |
patients receiving medication for post-operative nausea and/or vomiting
| Participants | Total Intravenous | Inhaled Anesthetic |
|---|---|---|
| Number of Patients Treated With Post-operative Anti-emetics | 27 | 20 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Total Intravenous | 0/37 (0%) | 0/37 (0%) | 0/37 (0%) |
| Inhaled Anesthetic | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| Age, Continuous(years) | Total Intravenous | Inhaled Anesthetic | Total |
|---|---|---|---|
| Mean | 45 (20 to 77) | 55 (25 to 81) | 51.5 (35.3 to 62) |
| Sex: Female, Male(Participants) | Total Intravenous | Inhaled Anesthetic | Total |
|---|---|---|---|
| Female | 16 | 11 | 27 |
| Male | 21 | 24 | 45 |
| Race and Ethnicity Not Collected(Participants) | Total Intravenous | Inhaled Anesthetic | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Total Intravenous | Inhaled Anesthetic | Total |
|---|---|---|---|
| United States | 37 | 35 | 72 |
| Body Mass Index (BMI)(kg/m^2) | Total Intravenous | Inhaled Anesthetic | Total |
|---|---|---|---|
| Mean | 31 (21 to 56) | 28 (19 to 53) | 29.1 (25.9 to 34.6) |
| American Society of Anesthesiologists (ASA) Physical Status(Participants) | Total Intravenous | Inhaled Anesthetic | Total |
|---|---|---|---|
| I | 2 | 3 | 5 |
| II | 28 | 25 | 53 |
| III | 7 | 7 | 14 |
| Disease Factors(participants) | Total Intravenous | Inhaled Anesthetic | Total |
|---|---|---|---|
| Polyposis | 31 | 33 | 64 |
| Tissue Eosinophilia | 28 | 30 | 58 |
| Allergic Fungal Rhinosinusitis (AFRS) | 5 | 3 | 8 |
| Aspirin Exacerbated Respiratory Disease (AERD) | 3 | 3 | 6 |
| Patient Assessments(units on a scale) | Total Intravenous | Inhaled Anesthetic | Total |
|---|---|---|---|
| Lund-Mackay Score | 14 (13 to 16) | 15 (13 to 20) | 14 (13 to 18) |
| SNOT-22 Score (Baseline) | 48 (37 to 59) | 45.5 (27 to 58) | 47 (34 to 58) |
1 further baseline measures are reported on the registry.
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