Advanced Chronic Rhinosinusitis
Conditions
Brief summary
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.
Detailed description
Specific Aims: 1. Determine the effect of total intravenous versus inhaled anesthesia on intraoperative visual field in endoscopic sinus surgery for advanced paranasal sinus disease 2. Evaluate clinical outcomes associated with choice of total intravenous versus inhaled anesthesia in endoscopic sinus surgery 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.
Interventions
DRUGPropofol
DRUGSevoflurane
Sponsors
Ochsner Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients undergoing endoscopic sinus surgery * Advanced inflammatory sinus disease, defined as allergic fungal sinusitis, chronic rhinosinusitis with nasal polyposis, chronic rhinosinusitis with eosinophilia, or rhinosinusitis with pan-sinus opacification (Lund-Mackay score \>12).
Exclusion criteria
* Noninflammatory sinonasal disease * Disease extending through the skull base or orbital wall * American Society of Anesthesiologists Preoperative Health Status \>II * Known non-pharmacologic coagulopathy (platelet \< 50000/mL, international normalized ratio \> 1.2) * Preoperative anticoagulants within 7 days of surgery * Allergy to one of the study medications * Age under 18 years * Non-English-speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Visual Field Assessment | Performed intraoperatively at the end of surgical case | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sinus-related Quality of Life | 3 months and 6 months | Sinonasal Outcomes Test (SNOT-22) (validated)- measures sinus symptoms. Minimum 0 Maximum 110. Higher scores indicate worse sinus symptoms. |
| Intraoperative Blood Loss | At time of surgery | Amount of blood loss (milliliters) during surgery |
| Surgical Time | At time of surgery | Total time spent in surgery (hours) |
| Post-anesthesia Care Unit Recovery Time | Immediately following surgery (postoperative day zero) | Hours spent in post-anesthesia care unit post-operatively |
| Number of Patients Treated With Post-operative Anti-emetics | 24 hours following surgery completion | patients receiving medication for post-operative nausea and/or vomiting |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Total Intravenous Intravenous propofol for maintenance of anesthesia
Propofol | 37 |
| Inhaled Anesthetic Inhaled volatile anesthetic for maintenance of anesthesia
Sevoflurane | 35 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Unplanned unilateral procedure | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total Intravenous | Inhaled Anesthetic | Total |
|---|---|---|---|
| Age, Continuous | 45 years | 55 years | 51.5 years |
| American Society of Anesthesiologists (ASA) Physical Status I | 2 Participants | 3 Participants | 5 Participants |
| American Society of Anesthesiologists (ASA) Physical Status II | 28 Participants | 25 Participants | 53 Participants |
| American Society of Anesthesiologists (ASA) Physical Status III | 7 Participants | 7 Participants | 14 Participants |
| Body Mass Index (BMI) | 31 kg/m^2 | 28 kg/m^2 | 29.1 kg/m^2 |
| Co-morbidities Chronic Obstructive Pulmonary Disease (COPD) | 3 participants | 4 participants | 7 participants |
| Co-morbidities Congestive Heart Failure | 1 participants | 0 participants | 1 participants |
| Co-morbidities Coronary Artery Disease | 1 participants | 1 participants | 2 participants |
| Co-morbidities Diabetes Mellitus | 2 participants | 3 participants | 5 participants |
| Co-morbidities Liver Disease | 2 participants | 0 participants | 2 participants |
| Co-morbidities Non-sinus Dysrhythmias | 0 participants | 1 participants | 1 participants |
| Co-morbidities Peripheral Vascular Disease | 3 participants | 1 participants | 4 participants |
| Co-morbidities Reactive Airway Disease | 16 participants | 16 participants | 32 participants |
| Co-morbidities Renal Disease | 0 participants | 2 participants | 2 participants |
| Co-morbidities Systemic Hypertension | 16 participants | 13 participants | 29 participants |
| Co-morbidities Tobacco Use | 8 participants | 13 participants | 21 participants |
| Disease Factors Allergic Fungal Rhinosinusitis (AFRS) | 5 participants | 3 participants | 8 participants |
| Disease Factors Aspirin Exacerbated Respiratory Disease (AERD) | 3 participants | 3 participants | 6 participants |
| Disease Factors Polyposis | 31 participants | 33 participants | 64 participants |
| Disease Factors Tissue Eosinophilia | 28 participants | 30 participants | 58 participants |
| Patient Assessments Lund-Mackay Score | 14 units on a scale | 15 units on a scale | 14 units on a scale |
| Patient Assessments SNOT-22 Score (Baseline) | 48 units on a scale | 45.5 units on a scale | 47 units on a scale |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 37 participants | 35 participants | 72 participants |
| Sex: Female, Male Female | 16 Participants | 11 Participants | 27 Participants |
| Sex: Female, Male Male | 21 Participants | 24 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 35 |
| other Total, other adverse events | 0 / 37 | 0 / 35 |
| serious Total, serious adverse events | 0 / 37 | 0 / 35 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Total Intravenous | Intraoperative Visual Field Assessment | Right Ethmoid | 3.3 units on a scale |
| Total Intravenous | Intraoperative Visual Field Assessment | Right Frontal | 3.3 units on a scale |
| Total Intravenous | Intraoperative Visual Field Assessment | Right Sphenoethmoidal Recess | 3.3 units on a scale |
| Total Intravenous | Intraoperative Visual Field Assessment | Right Choana | 2.7 units on a scale |
| Total Intravenous | Intraoperative Visual Field Assessment | Left Frontal | 3.3 units on a scale |
| Total Intravenous | Intraoperative Visual Field Assessment | Left Ethmoid | 3.3 units on a scale |
| Total Intravenous | Intraoperative Visual Field Assessment | Left Sphenoethmoidal Recess | 3.3 units on a scale |
| Total Intravenous | Intraoperative Visual Field Assessment | Left Choana | 3.0 units on a scale |
| Inhaled Anesthetic | Intraoperative Visual Field Assessment | Left Choana | 3.7 units on a scale |
| Inhaled Anesthetic | Intraoperative Visual Field Assessment | Left Frontal | 4.0 units on a scale |
| Inhaled Anesthetic | Intraoperative Visual Field Assessment | Right Frontal | 4.3 units on a scale |
| Inhaled Anesthetic | Intraoperative Visual Field Assessment | Right Ethmoid | 4.2 units on a scale |
| Inhaled Anesthetic | Intraoperative Visual Field Assessment | Left Sphenoethmoidal Recess | 4.3 units on a scale |
| Inhaled Anesthetic | Intraoperative Visual Field Assessment | Right Sphenoethmoidal Recess | 4.8 units on a scale |
| Inhaled Anesthetic | Intraoperative Visual Field Assessment | Left Ethmoid | 4.3 units on a scale |
| Inhaled Anesthetic | Intraoperative Visual Field Assessment | Right Choana | 3.3 units on a scale |
Secondary
Intraoperative Blood Loss
Amount of blood loss (milliliters) during surgery
Time frame: At time of surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Total Intravenous | Intraoperative Blood Loss | 200 mL |
| Inhaled Anesthetic | Intraoperative Blood Loss | 300 mL |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Intravenous | Number of Patients Treated With Post-operative Anti-emetics | 27 Participants |
| Inhaled Anesthetic | Number of Patients Treated With Post-operative Anti-emetics | 20 Participants |
Secondary
Post-anesthesia Care Unit Recovery Time
Hours spent in post-anesthesia care unit post-operatively
Time frame: Immediately following surgery (postoperative day zero)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Total Intravenous | Post-anesthesia Care Unit Recovery Time | 1.3 hours |
| Inhaled Anesthetic | Post-anesthesia Care Unit Recovery Time | 1.7 hours |
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.
Time frame: 3 months and 6 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Total Intravenous | Sinus-related Quality of Life | 3 months | 20.1 units on a scale |
| Total Intravenous | Sinus-related Quality of Life | 6 months | 21.5 units on a scale |
| Inhaled Anesthetic | Sinus-related Quality of Life | 3 months | 14.2 units on a scale |
| Inhaled Anesthetic | Sinus-related Quality of Life | 6 months | 15.2 units on a scale |
Secondary
Surgical Time
Total time spent in surgery (hours)
Time frame: At time of surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Total Intravenous | Surgical Time | 3.4 hours |
| Inhaled Anesthetic | Surgical Time | 3.4 hours |