Phase 4 N=72 Randomized Double-blind Treatment

Total Intravenous Anesthesia in Sinus Surgery

Advanced Chronic Rhinosinusitis

Bottom Line

View on ClinicalTrials.gov: NCT02578862 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2018

Primary outcome: Primary: Intraoperative Visual Field Assessment — 3.3; 4.3; 3.3; 4.2 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Propofol (Drug); Sevoflurane (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ochsner Health System
Primary completion: Jun 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Intraoperative Visual Field Assessment	3.3; 4.3; 3.3; 4.2; 3.3; 4.8	—
SECONDARY Sinus-related Quality of Life	20.1; 14.2; 21.5; 15.2	—
SECONDARY Intraoperative Blood Loss	200; 300	—
SECONDARY Surgical Time	3.4; 3.4	—
SECONDARY Post-anesthesia Care Unit Recovery Time	1.3; 1.7	—
SECONDARY Number of Patients Treated With Post-operative Anti-emetics	27; 20	—

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.

Eligibility Criteria

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 1.2)
Preoperative anticoagulants within 7 days of surgery
Allergy to one of the study medications
Age under 18 years
Non-English-speaking

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Data sourced from ClinicalTrials.gov (NCT02578862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.