Trial Outcomes & Findings for Effects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery (NCT NCT05867342)
NCT ID: NCT05867342
Last Updated: 2023-07-10
Results Overview
The video recording of the endoscopic sinus surgery of the participant was graded by another otolaryngology specialist postoperatively and graded according to Wormald Surgical Field Grading Scale. Scores range from 0 (no bleeding) to 10 (severe bleeding with nasal cavity filling rapidly).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
postoperatively (approximately 20 minutes to assess)
Results posted on
2023-07-10
Participant Flow
Unit of analysis: nostrils
Participant milestones
| Measure |
1:1000 Epinephrine Plus Saline
Participants receive topical 1:1000 epinephrine plus saline in one nostril, and topical 1:1000 epinephrine plus infiltration of 1% lidocaine with 1:100,000 epinephrine in the other nostril, during endoscopic visualization while undergoing Endoscopic sinus surgery (ESS).
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1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine
Participants receive topical 1:1000 epinephrine plus saline in one nostril, and topical 1:1000 epinephrine plus infiltration of 1% lidocaine with 1:100,000 epinephrine in the other nostril, during endoscopic visualization while undergoing Endoscopic sinus surgery (ESS).
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|---|---|---|
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Overall Study
STARTED
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40 40
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40 40
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Overall Study
COMPLETED
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37 37
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37 37
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Overall Study
NOT COMPLETED
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3 3
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3 3
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Reasons for withdrawal
| Measure |
1:1000 Epinephrine Plus Saline
Participants receive topical 1:1000 epinephrine plus saline in one nostril, and topical 1:1000 epinephrine plus infiltration of 1% lidocaine with 1:100,000 epinephrine in the other nostril, during endoscopic visualization while undergoing Endoscopic sinus surgery (ESS).
|
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine
Participants receive topical 1:1000 epinephrine plus saline in one nostril, and topical 1:1000 epinephrine plus infiltration of 1% lidocaine with 1:100,000 epinephrine in the other nostril, during endoscopic visualization while undergoing Endoscopic sinus surgery (ESS).
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|---|---|---|
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Overall Study
Investigator Decision
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3
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3
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Participants
n=40 Participants
Participants receive topical 1:1000 epinephrine plus saline in one nostril, and topical 1:1000 epinephrine plus infiltration of 1% lidocaine with 1:100,000 epinephrine in the other nostril.
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|---|---|
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Age, Continuous
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49.46 years
STANDARD_DEVIATION 16.34 • n=40 Participants
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Sex: Female, Male
Female
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22 Participants
n=40 Participants
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Sex: Female, Male
Male
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18 Participants
n=40 Participants
|
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Region of Enrollment
United States
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40 Participants
n=40 Participants
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PRIMARY outcome
Timeframe: postoperatively (approximately 20 minutes to assess)Population: Intention-to-treat analysis set
The video recording of the endoscopic sinus surgery of the participant was graded by another otolaryngology specialist postoperatively and graded according to Wormald Surgical Field Grading Scale. Scores range from 0 (no bleeding) to 10 (severe bleeding with nasal cavity filling rapidly).
Outcome measures
| Measure |
1:1000 Epinephrine Plus Saline
n=40 nostrils
Participants receive topical 1:1000 epinephrine plus saline in one nostril, and topical 1:1000 epinephrine plus infiltration of 1% lidocaine with 1:100,000 epinephrine in the other nostril.
|
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine
n=40 nostrils
Participants receive topical 1:1000 epinephrine plus saline in one nostril, and topical 1:1000 epinephrine plus infiltration of 1% lidocaine with 1:100,000 epinephrine in the other nostril.
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|---|---|---|
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Surgical Field Grading Score
|
3.54 score on a scale
Standard Deviation 0.96
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3.23 score on a scale
Standard Deviation 1.14
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SECONDARY outcome
Timeframe: intraoperatively (up to 3 hours)Population: Intention-to-treat analysis set
Outcome measures
| Measure |
1:1000 Epinephrine Plus Saline
n=40 nostrils
Participants receive topical 1:1000 epinephrine plus saline in one nostril, and topical 1:1000 epinephrine plus infiltration of 1% lidocaine with 1:100,000 epinephrine in the other nostril.
|
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine
n=40 nostrils
Participants receive topical 1:1000 epinephrine plus saline in one nostril, and topical 1:1000 epinephrine plus infiltration of 1% lidocaine with 1:100,000 epinephrine in the other nostril.
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|---|---|---|
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Duration of Surgery
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72.05 minutes
Standard Deviation 35.74
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54.23 minutes
Standard Deviation 22.27
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SECONDARY outcome
Timeframe: intraoperatively (up to 3 hours)Population: Intention-to-treat analysis set
A pledget is a small wad of absorbent material used to stop bleeding.
Outcome measures
| Measure |
1:1000 Epinephrine Plus Saline
n=40 nostrils
Participants receive topical 1:1000 epinephrine plus saline in one nostril, and topical 1:1000 epinephrine plus infiltration of 1% lidocaine with 1:100,000 epinephrine in the other nostril.
|
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine
n=40 nostrils
Participants receive topical 1:1000 epinephrine plus saline in one nostril, and topical 1:1000 epinephrine plus infiltration of 1% lidocaine with 1:100,000 epinephrine in the other nostril.
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|---|---|---|
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Number of Extra Pledgets Used
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3.25 pledgets
Standard Deviation 2.82
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2.63 pledgets
Standard Deviation 3.2
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SECONDARY outcome
Timeframe: intraoperatively (up to 3 hours)Population: Intention-to-treat analysis set
Outcome measures
| Measure |
1:1000 Epinephrine Plus Saline
n=40 nostrils
Participants receive topical 1:1000 epinephrine plus saline in one nostril, and topical 1:1000 epinephrine plus infiltration of 1% lidocaine with 1:100,000 epinephrine in the other nostril.
|
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine
n=40 nostrils
Participants receive topical 1:1000 epinephrine plus saline in one nostril, and topical 1:1000 epinephrine plus infiltration of 1% lidocaine with 1:100,000 epinephrine in the other nostril.
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|---|---|---|
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Estimated Blood Loss During Surgery
|
95.25 mL
Standard Deviation 82.88
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91.63 mL
Standard Deviation 86.98
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SECONDARY outcome
Timeframe: 1 week after the surgery (up to 2 minutes to complete assessment)Population: Intention-to-treat analysis set
Grading of postoperative bloody discharge postoperatively assessed by patient using the 1-week postoperative bleeding questionnaire. Scores range from 0 (no bleeding) to 5 (continuous heavy bleeding necessitating medical care).
Outcome measures
| Measure |
1:1000 Epinephrine Plus Saline
n=40 nostrils
Participants receive topical 1:1000 epinephrine plus saline in one nostril, and topical 1:1000 epinephrine plus infiltration of 1% lidocaine with 1:100,000 epinephrine in the other nostril.
|
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine
n=40 nostrils
Participants receive topical 1:1000 epinephrine plus saline in one nostril, and topical 1:1000 epinephrine plus infiltration of 1% lidocaine with 1:100,000 epinephrine in the other nostril.
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|---|---|---|
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Postoperative Bloody Discharge Grading Score
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2.38 score on a scale
Standard Deviation 1.14
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2.2 score on a scale
Standard Deviation 0.213
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SECONDARY outcome
Timeframe: 1 week after the surgery (up to 2 minutes to complete assessment)Population: Intention-to-treat analysis set
Participants indicated number of days with bloody nasal discharge postoperatively using the 1-week postoperative bleeding questionnaire.
Outcome measures
| Measure |
1:1000 Epinephrine Plus Saline
n=40 nostrils
Participants receive topical 1:1000 epinephrine plus saline in one nostril, and topical 1:1000 epinephrine plus infiltration of 1% lidocaine with 1:100,000 epinephrine in the other nostril.
|
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine
n=40 nostrils
Participants receive topical 1:1000 epinephrine plus saline in one nostril, and topical 1:1000 epinephrine plus infiltration of 1% lidocaine with 1:100,000 epinephrine in the other nostril.
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|---|---|---|
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Number of Days With Postoperative Bloody Nasal Discharge
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2.85 days
Standard Deviation 2.54
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2.73 days
Standard Deviation 2.35
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SECONDARY outcome
Timeframe: 1 week after the surgery (up to 2 minutes to complete assessment)Population: Intention-to-treat analysis set
Number of nostrils with excessive fresh bleeding postoperatively using the 1-week postoperative bleeding questionnaire. Continuous fresh bleeding was defined as bleeding for over 15 minutes.
Outcome measures
| Measure |
1:1000 Epinephrine Plus Saline
n=40 nostrils
Participants receive topical 1:1000 epinephrine plus saline in one nostril, and topical 1:1000 epinephrine plus infiltration of 1% lidocaine with 1:100,000 epinephrine in the other nostril.
|
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine
n=40 nostrils
Participants receive topical 1:1000 epinephrine plus saline in one nostril, and topical 1:1000 epinephrine plus infiltration of 1% lidocaine with 1:100,000 epinephrine in the other nostril.
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|---|---|---|
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Number of Nostrils With Continuous Fresh Bleeding
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7 nostrils
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5 nostrils
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Adverse Events
1:1000 Epinephrine Plus Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place