Total Intravenous Anesthesia in Sinus Surgery

NCT02578862 | Completed Phase 4 Results DMC

• 1 other identifier: 2015.131.A
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Chronic Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• 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)

  Performed intraoperatively at the end of surgical case

Secondary Outcomes (5)

• Sinus-related Quality of Life

  3 months and 6 months

• Intraoperative Blood Loss

  At time of surgery

• Surgical Time

  At time of surgery

• Post-anesthesia Care Unit Recovery Time

  Immediately following surgery (postoperative day zero)

• Number of Patients Treated With Post-operative Anti-emetics

  24 hours following surgery completion

Study Arms (2)

Total Intravenous

EXPERIMENTAL

Intravenous propofol for maintenance of anesthesia

Drug: Propofol

Inhaled Anesthetic

ACTIVE COMPARATOR

Inhaled volatile anesthetic for maintenance of anesthesia

Drug: Sevoflurane

Interventions

Propofol DRUG

Total Intravenous

Sevoflurane DRUG

Also known as: Isoflurane

Inhaled Anesthetic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Ochsner Health System: lead

Study Sites (1)

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Related Publications (1)

• 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.

  PMID: 29979837 DERIVED

MeSH Terms

Interventions

Propofol; Sevoflurane; Isoflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Limitations and Caveats

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.

Results Point of Contact

• Title: Edward D McCoul, MD, MPH
• Organization: Ochsner Medical Center

edward.mccoul@ochsner.org

504-842-4080

Study Officials

• Edward D McCoul, MD,MPH

  Ochsner Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Active Medical Staff

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 19, 2015
• Study Start: July 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: December 21, 2018
• Results First Posted: December 21, 2018

Record last verified: 2018-11

Locations

US (1)