Total Intravenous Anesthesia in Sinus Surgery
| Status: | Completed |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/23/2018 |
| Start Date: | July 2015 |
| End Date: | June 2018 |
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.
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.
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.
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.
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
We found this trial at
1
site
1514 Jefferson Hwy.
New Orleans, Louisiana 70121
New Orleans, Louisiana 70121
504-842-3000
Phone: 504-842-4080
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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