Total Intravenous Anesthesia in Sinus Surgery

Total Intravenous Versus Inhaled Anesthesia in Endoscopic Sinus Surgery for High-Grade Paranasal Disease

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.

Study Overview

• Status: Completed
• Conditions: Advanced Chronic Rhinosinusitis
• Intervention / Treatment: Drug: Propofol; Drug: Sevoflurane

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Total Intravenous; Intravenous propofol for maintenance of anesthesia	Drug: Propofol
Active Comparator: Inhaled Anesthetic; Inhaled volatile anesthetic for maintenance of anesthesia	Drug: Sevoflurane; Other Names: Isoflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Visual Field Assessment	Wormald Visualization Scale (validated) Grade Assessment (0-10) -Higher scores indicate worsening visualization 0 No bleeding; 1-2 points of ooze; 3-4 points of ooze; 5-6 points of ooze; 7-8 points of ooze; 9-10 points of ooze (sphenoid fills in 60 seconds)*; 10 points of ooze, obscuring surface (sphenoid fills in 50 seconds)*; Mild bleeding/oozing from entire surgical surface with slow accumulation of blood in the post nasal space (sphenoid fills by 40 seconds); Moderate bleeding from entire surgical surface with moderate accumulation of blood in the post nasal space at (sphenoid fills by 30 seconds); Moderately severe bleeding with rapid accumulation of blood in the post nasal space (sphenoid fills by 20 seconds); Severe bleeding with nasal cavity filling rapidly(sphenoid fills in10 seconds)	Performed intraoperatively at the end of surgical case

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Ochsner Health System
• Investigators: Principal Investigator: Edward D McCoul, MD,MPH, Ochsner Health System

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: October 14, 2015
• First Submitted That Met QC Criteria: October 16, 2015
• First Posted (Estimate): October 19, 2015

Study Record Updates

• Last Update Posted (Actual): December 21, 2018
• Last Update Submitted That Met QC Criteria: November 30, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Sevoflurane; Isoflurane
• Other Study ID Numbers: 2015.131.A