Total Intravenous Anesthesia in Sinus Surgery

NCT ID: NCT02578862

Last Updated: 2018-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2018-06-30

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.

Conditions

Advanced Chronic Rhinosinusitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Total Intravenous

Intravenous propofol for maintenance of anesthesia

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

Inhaled Anesthetic

Inhaled volatile anesthetic for maintenance of anesthesia

Group Type: ACTIVE_COMPARATOR

Sevoflurane

Intervention Type: DRUG

Interventions

Propofol

Intervention Type: DRUG

Sevoflurane

Intervention Type: DRUG

Other Intervention Names

Isoflurane

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 < 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ochsner Health System

OTHER

Sponsor Role: lead

Responsible Party

Edward Mccoul, MD

Active Medical Staff

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward D McCoul, MD,MPH

Role: PRINCIPAL_INVESTIGATOR

Ochsner Health System

Locations

Ochsner Medical Center

New Orleans, Louisiana, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29979837 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015.131.A

Identifier Type: -

Identifier Source: org_study_id