Total Intravenous Anesthesia in Sinus Surgery

Phase 4

Completed

Conditions: Advanced Chronic Rhinosinusitis

Interventions: Drug: Propofol
Drug: Sevoflurane

Registration Number: NCT02578862

Lead Sponsor: Ochsner Health System

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 72

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total Intravenous	Propofol	Intravenous propofol for maintenance of anesthesia
Inhaled Anesthetic	Sevoflurane	Inhaled volatile anesthetic for maintenance of anesthesia

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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