Advanced Chronic RhinosinusitisPhase 4NCT02578862

Total Intravenous Anesthesia in Sinus Surgery

A Phase 4 study testing Propofol and Sevoflurane in people with Advanced Chronic Rhinosinusitis, run by Ochsner Health System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Advanced Chronic Rhinosinusitis
What is being tested?: Propofol and Sevoflurane
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteUnited States
Study dates: Jul 2015to Jun 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Ochsner Medical Center
New Orleans, Louisiana, 70121

Other trials in United States

About this study

Official title: 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.

Read the detailed description

Specific Aims:

Determine the effect of total intravenous versus inhaled anesthesia on intraoperative visual field in endoscopic sinus surgery for advanced paranasal sinus disease
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
Being tested: Propofol, Sevoflurane

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PropofolDrug
SevofluraneDrug
Also called Isoflurane

Study groups in NCT02578862
Study group	Role	What they receive
Total Intravenous	Experimental	Intravenous propofol for maintenance of anesthesia Receives: Drug: Propofol
Inhaled Anesthetic	Active comparator	Inhaled volatile anesthetic for maintenance of anesthesia Receives: Drug: Sevoflurane

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: Performed intraoperatively at the end of surgical case

Secondary outcomes (5)

Sinus-related Quality of Life
Sinonasal Outcomes Test (SNOT-22) (validated)- measures sinus symptoms. Minimum 0 Maximum 110. Higher scores indicate worse sinus symptoms.
Measured: 3 months and 6 months
Intraoperative Blood Loss
Amount of blood loss (milliliters) during surgery
Measured: At time of surgery
Surgical Time
Total time spent in surgery (hours)
Measured: At time of surgery
Post-anesthesia Care Unit Recovery Time
Hours spent in post-anesthesia care unit post-operatively
Measured: 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
Measured: 24 hours following surgery completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2015Jun 2018

First posted19 Oct 2015 (estimated)
Study startJul 2015
Primary completionJun 2018
Study completionJun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Advanced Chronic RhinosinusitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02578862
Sponsor's protocol ID: 2015.131.A
Status last verified: Nov 2018
First submitted: 14 Oct 2015
Last updated: 21 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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.
PubMed 29979837

Study at a glance

From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Total Intravenous Versus Inhaled Anesthesia in Endoscopic Sinus Surgery for High-Grade Paranasal Disease
ClinicalTrials.gov ID: NCT02578862
Acronym / sponsor ID: 2015.131.A
Conditions: Advanced Chronic Rhinosinusitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Ochsner Health SystemUniversity, hospital or other
Study start: Jul 2015 (actual)
Primary completion: Jun 2018 (actual)
Study completion: Jun 2018 (actual)
First posted: 19 Oct 2015 (estimated)
Results: Posted 21 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Specific Aims:

Determine the effect of total intravenous versus inhaled anesthesia on intraoperative visual field in endoscopic sinus surgery for advanced paranasal sinus disease
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:

Method for Assigning Subjects to Treatment Groups:

Blinding of Study Drug:

Study Procedures:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Total Intravenous	Experimental	Drug: PropofolIntravenous propofol for maintenance of anesthesia
Inhaled Anesthetic	Active comparator	Drug: SevofluraneInhaled volatile anesthetic for maintenance of anesthesia

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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).

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Propofol	Drug	Total Intravenous
SevofluraneAlso: Isoflurane	Drug	Inhaled Anesthetic

Primary outcome

Intraoperative Visual Field Assessment
Time frame: 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)

5 secondary outcomes

Sinus-related Quality of Life
Time frame: 3 months and 6 months
Intraoperative Blood Loss
Time frame: At time of surgery
Surgical Time
Time frame: At time of surgery
Post-anesthesia Care Unit Recovery Time
Time frame: Immediately following surgery (postoperative day zero)
Number of Patients Treated With Post-operative Anti-emetics
Time frame: 24 hours following surgery completion

Results and safety

Results posted to the registry on 21 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Total Intravenous	37	37
Inhaled Anesthetic	35	33

Primary outcome: Intraoperative Visual Field Assessment

Time frame: Performed intraoperatively at the end of surgical case. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Total Intravenous n = 37	Inhaled Anesthetic n = 35
Right Frontal	3.3 (2.0 to 4.3)	4.3 (2.8 to 5.6)
Right Ethmoid	3.3 (2.1 to 4.3)	4.2 (3.3 to 5.9)
Right Sphenoethmoidal Recess	3.3 (2.7 to 4.3)	4.8 (3.7 to 6.3)
Right Choana	2.7 (2.3 to 3.3)	3.3 (2.2 to 5.0)
Left Frontal	3.3 (2.7 to 4.8)	4.0 (3.3 to 5.3)
Left Ethmoid	3.3 (2.7 to 4.3)	4.3 (3.3 to 6.3)
Left Sphenoethmoidal Recess	3.3 (2.3 to 4.3)	4.3 (3.0 to 6.7)
Left Choana	3.0 (2.3 to 3.7)	3.7 (2.7 to 5.0)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Total Intravenous	0 of 37 (0%)	0 of 37 (0%)	0 of 37
Inhaled Anesthetic	0 of 35 (0%)	0 of 35 (0%)	0 of 35

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29979837Brunner 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Edward D McCoul, MD,MPH principal investigator

Ochsner Health System

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Propofol and Sevoflurane in people with Advanced Chronic Rhinosinusitis, run by Ochsner Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraoperative Visual Field Assessment (time frame: Performed intraoperatively at the end of surgical case). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02578862, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2018.