Trial Outcomes & Findings for Total Intravenous Anesthesia in Sinus Surgery (NCT NCT02578862)

Last Updated: 2018-12-21

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

72 participants

Primary outcome timeframe

Performed intraoperatively at the end of surgical case

Results posted on

2018-12-21

Participant Flow

Participant milestones

Participant milestones
Measure	Total Intravenous Intravenous propofol for maintenance of anesthesia Propofol	Inhaled Anesthetic Inhaled volatile anesthetic for maintenance of anesthesia Sevoflurane
Overall Study STARTED	37	35
Overall Study COMPLETED	37	33
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Total Intravenous Intravenous propofol for maintenance of anesthesia Propofol	Inhaled Anesthetic Inhaled volatile anesthetic for maintenance of anesthesia Sevoflurane
Overall Study Withdrawal by Subject	0	1
Overall Study Unplanned unilateral procedure	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Intravenous n=37 Participants Intravenous propofol for maintenance of anesthesia Propofol	Inhaled Anesthetic n=35 Participants Inhaled volatile anesthetic for maintenance of anesthesia Sevoflurane	Total n=72 Participants Total of all reporting groups
Age, Continuous	45 years n=37 Participants	55 years n=35 Participants	51.5 years n=72 Participants
Sex: Female, Male Female	16 Participants n=37 Participants	11 Participants n=35 Participants	27 Participants n=72 Participants
Sex: Female, Male Male	21 Participants n=37 Participants	24 Participants n=35 Participants	45 Participants n=72 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	37 participants n=37 Participants	35 participants n=35 Participants	72 participants n=72 Participants
Body Mass Index (BMI)	31 kg/m^2 n=37 Participants	28 kg/m^2 n=35 Participants	29.1 kg/m^2 n=72 Participants
American Society of Anesthesiologists (ASA) Physical Status I	2 Participants n=37 Participants	3 Participants n=35 Participants	5 Participants n=72 Participants
American Society of Anesthesiologists (ASA) Physical Status II	28 Participants n=37 Participants	25 Participants n=35 Participants	53 Participants n=72 Participants
American Society of Anesthesiologists (ASA) Physical Status III	7 Participants n=37 Participants	7 Participants n=35 Participants	14 Participants n=72 Participants
Disease Factors Polyposis	31 participants n=37 Participants	33 participants n=35 Participants	64 participants n=72 Participants
Disease Factors Tissue Eosinophilia	28 participants n=37 Participants	30 participants n=35 Participants	58 participants n=72 Participants
Disease Factors Allergic Fungal Rhinosinusitis (AFRS)	5 participants n=37 Participants	3 participants n=35 Participants	8 participants n=72 Participants
Disease Factors Aspirin Exacerbated Respiratory Disease (AERD)	3 participants n=37 Participants	3 participants n=35 Participants	6 participants n=72 Participants
Patient Assessments Lund-Mackay Score	14 units on a scale n=37 Participants	15 units on a scale n=35 Participants	14 units on a scale n=72 Participants
Patient Assessments SNOT-22 Score (Baseline)	48 units on a scale n=37 Participants	45.5 units on a scale n=35 Participants	47 units on a scale n=72 Participants
Co-morbidities Systemic Hypertension	16 participants n=37 Participants	13 participants n=35 Participants	29 participants n=72 Participants
Co-morbidities Diabetes Mellitus	2 participants n=37 Participants	3 participants n=35 Participants	5 participants n=72 Participants
Co-morbidities Reactive Airway Disease	16 participants n=37 Participants	16 participants n=35 Participants	32 participants n=72 Participants
Co-morbidities Coronary Artery Disease	1 participants n=37 Participants	1 participants n=35 Participants	2 participants n=72 Participants
Co-morbidities Renal Disease	0 participants n=37 Participants	2 participants n=35 Participants	2 participants n=72 Participants
Co-morbidities Non-sinus Dysrhythmias	0 participants n=37 Participants	1 participants n=35 Participants	1 participants n=72 Participants
Co-morbidities Congestive Heart Failure	1 participants n=37 Participants	0 participants n=35 Participants	1 participants n=72 Participants
Co-morbidities Tobacco Use	8 participants n=37 Participants	13 participants n=35 Participants	21 participants n=72 Participants
Co-morbidities Chronic Obstructive Pulmonary Disease (COPD)	3 participants n=37 Participants	4 participants n=35 Participants	7 participants n=72 Participants
Co-morbidities Peripheral Vascular Disease	3 participants n=37 Participants	1 participants n=35 Participants	4 participants n=72 Participants
Co-morbidities Liver Disease	2 participants n=37 Participants	0 participants n=35 Participants	2 participants n=72 Participants

PRIMARY outcome

Timeframe: Performed intraoperatively at the end of surgical case

Outcome measures

Outcome measures
Measure	Total Intravenous n=37 Participants Intravenous propofol for maintenance of anesthesia Propofol	Inhaled Anesthetic n=35 Participants Inhaled volatile anesthetic for maintenance of anesthesia Sevoflurane
Intraoperative Visual Field Assessment Right Sphenoethmoidal Recess	3.3 units on a scale Interval 2.7 to 4.3	4.8 units on a scale Interval 3.7 to 6.3
Intraoperative Visual Field Assessment Right Choana	2.7 units on a scale Interval 2.3 to 3.3	3.3 units on a scale Interval 2.2 to 5.0
Intraoperative Visual Field Assessment Left Frontal	3.3 units on a scale Interval 2.7 to 4.8	4.0 units on a scale Interval 3.3 to 5.3
Intraoperative Visual Field Assessment Left Sphenoethmoidal Recess	3.3 units on a scale Interval 2.3 to 4.3	4.3 units on a scale Interval 3.0 to 6.7
Intraoperative Visual Field Assessment Left Choana	3.0 units on a scale Interval 2.3 to 3.7	3.7 units on a scale Interval 2.7 to 5.0
Intraoperative Visual Field Assessment Right Frontal	3.3 units on a scale Interval 2.0 to 4.3	4.3 units on a scale Interval 2.8 to 5.6
Intraoperative Visual Field Assessment Right Ethmoid	3.3 units on a scale Interval 2.1 to 4.3	4.2 units on a scale Interval 3.3 to 5.9
Intraoperative Visual Field Assessment Left Ethmoid	3.3 units on a scale Interval 2.7 to 4.3	4.3 units on a scale Interval 3.3 to 6.3

SECONDARY outcome

Timeframe: 3 months and 6 months

Sinonasal Outcomes Test (SNOT-22) (validated)- measures sinus symptoms. Minimum 0 Maximum 110. Higher scores indicate worse sinus symptoms.

Outcome measures

Outcome measures
Measure	Total Intravenous n=37 Participants Intravenous propofol for maintenance of anesthesia Propofol	Inhaled Anesthetic n=35 Participants Inhaled volatile anesthetic for maintenance of anesthesia Sevoflurane
Sinus-related Quality of Life 3 months	20.1 units on a scale Interval 12.6 to 27.6	14.2 units on a scale Interval 6.4 to 22.0
Sinus-related Quality of Life 6 months	21.5 units on a scale Interval 10.0 to 33.0	15.2 units on a scale Interval 5.9 to 24.6

SECONDARY outcome

Timeframe: At time of surgery

Amount of blood loss (milliliters) during surgery

Outcome measures

Outcome measures
Measure	Total Intravenous n=37 Participants Intravenous propofol for maintenance of anesthesia Propofol	Inhaled Anesthetic n=35 Participants Inhaled volatile anesthetic for maintenance of anesthesia Sevoflurane
Intraoperative Blood Loss	200 mL Interval 100.0 to 450.0	300 mL Interval 200.0 to 500.0

SECONDARY outcome

Timeframe: At time of surgery

Total time spent in surgery (hours)

Outcome measures

Outcome measures
Measure	Total Intravenous n=37 Participants Intravenous propofol for maintenance of anesthesia Propofol	Inhaled Anesthetic n=35 Participants Inhaled volatile anesthetic for maintenance of anesthesia Sevoflurane
Surgical Time	3.4 hours Interval 2.9 to 3.9	3.4 hours Interval 2.8 to 4.0

SECONDARY outcome

Timeframe: Immediately following surgery (postoperative day zero)

Hours spent in post-anesthesia care unit post-operatively

Outcome measures

Outcome measures
Measure	Total Intravenous n=37 Participants Intravenous propofol for maintenance of anesthesia Propofol	Inhaled Anesthetic n=35 Participants Inhaled volatile anesthetic for maintenance of anesthesia Sevoflurane
Post-anesthesia Care Unit Recovery Time	1.3 hours Interval 1.0 to 1.6	1.7 hours Interval 1.2 to 2.5

SECONDARY outcome

Timeframe: 24 hours following surgery completion

patients receiving medication for post-operative nausea and/or vomiting

Outcome measures

Outcome measures
Measure	Total Intravenous n=37 Participants Intravenous propofol for maintenance of anesthesia Propofol	Inhaled Anesthetic n=35 Participants Inhaled volatile anesthetic for maintenance of anesthesia Sevoflurane
Number of Patients Treated With Post-operative Anti-emetics	27 Participants	20 Participants

Adverse Events

Total Intravenous

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Inhaled Anesthetic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Edward D McCoul, MD, MPH

Ochsner Medical Center

Phone: 504-842-4080

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place