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In endoscopic sinus surgery a clear surgical field of view is a very important aspect for good surgical outcome. This study is to evaluate the preoperative preparation to acquire best surgical field of view by comparing between the use of topical adrenaline and the use of combination of topical adrenaline with infiltration of 1% lidocaine with adrenaline in patients scheduled for endoscopic sinus surgery for rhinosinusitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic sinus surgery | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epinephrin | Drug | Topical application of 2 pieces of Epinephrin (1:1,000)-soaked cottonoid in nasal cavity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Field Grading Score | 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). | postoperatively (approximately 20 minutes to assess) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Surgery | intraoperatively (up to 3 hours) | |
| Number of Extra Pledgets Used | A pledget is a small wad of absorbent material used to stop bleeding. | intraoperatively (up to 3 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter H Hwang, MD | Stanford University | Study Director |
| Navarat Tangbumrungtham, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford | Stanford | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26452438 | Background | Saif AM, Farboud A, Delfosse E, Pope L, Adke M. Assessing the safety and efficacy of drugs used in preparing the nose for diagnostic and therapeutic procedures: a systematic review. Clin Otolaryngol. 2016 Oct;41(5):546-63. doi: 10.1111/coa.12563. Epub 2016 Feb 11. | |
| 16959188 | Background | Yang JJ, Zheng J, Liu HJ, Liu YX, Shen JC, Zhou ZQ. Epinephrine infiltration on nasal field causes significant hemodynamic changes: hypotension episode monitored by impedance-cardiography under general anesthesia. J Pharm Pharm Sci. 2006;9(2):190-7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Surgical Field Grading Score | 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). | Intention-to-treat analysis set | Posted | Mean | Standard Deviation | score on a scale | postoperatively (approximately 20 minutes to assess) | nostrils | nostrils |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter H. Hwang, MD | Stanford University | (650) 725-6500 | hwangph@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 27, 2018 | May 19, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 1, 2020 | May 19, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| D008012 | Lidocaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| 1% lidocaine with epinephrin 1:100,000 | Drug | 4 ml intranasal infiltration of 1% lidocaine with epinephrine (1:100,000) at 2 sites (2 ml infiltration at each site) |
|
| Saline | Drug | 4 ml intranasal infiltration of saline at 2 sites (2 ml infiltration at each site) |
|
| Estimated Blood Loss During Surgery | intraoperatively (up to 3 hours) |
| Postoperative Bloody Discharge Grading Score | 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). | 1 week after the surgery (up to 2 minutes to complete assessment) |
| Number of Days With Postoperative Bloody Nasal Discharge | Participants indicated number of days with bloody nasal discharge postoperatively using the 1-week postoperative bleeding questionnaire. | 1 week after the surgery (up to 2 minutes to complete assessment) |
| Number of Nostrils With Continuous Fresh Bleeding | 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. | 1 week after the surgery (up to 2 minutes to complete assessment) |
| 16223392 | Background | Yang JJ, Li WY, Jil Q, Wang ZY, Sun J, Wang QP, Li ZQ, Xu JG. Local anesthesia for functional endoscopic sinus surgery employing small volumes of epinephrine-containing solutions of lidocaine produces profound hypotension. Acta Anaesthesiol Scand. 2005 Nov;49(10):1471-6. doi: 10.1111/j.1399-6576.2005.00869.x. |
| 19841339 | Background | Moshaver A, Lin D, Pinto R, Witterick IJ. The hemostatic and hemodynamic effects of epinephrine during endoscopic sinus surgery: a randomized clinical trial. Arch Otolaryngol Head Neck Surg. 2009 Oct;135(10):1005-9. doi: 10.1001/archoto.2009.144. |
| 23255493 | Background | Khosla AJ, Pernas FG, Maeso PA. Meta-analysis and literature review of techniques to achieve hemostasis in endoscopic sinus surgery. Int Forum Allergy Rhinol. 2013 Jun;3(6):482-7. doi: 10.1002/alr.21126. Epub 2012 Dec 16. |
| 18438267 | Background | Cohen-Kerem R, Brown S, Villasenor LV, Witterick I. Epinephrine/Lidocaine injection vs. saline during endoscopic sinus surgery. Laryngoscope. 2008 Jul;118(7):1275-81. doi: 10.1097/MLG.0b013e31816dd2d9. |
| 31671251 | Result | Tangbumrungtham N, Hwang PH, Maul X, Borchard NA, Dholakia SS, Patel ZM, Nayak JV, Choby G. The effect of topical epinephrine 1:1000 with and without infiltration of 1% lidocaine with epinephrine 1:100,000 on endoscopic surgical field visualization: a double-blind randomized controlled study. Int Forum Allergy Rhinol. 2020 Feb;10(2):147-152. doi: 10.1002/alr.22468. Epub 2019 Oct 31. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | 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. |
|
|
|
| Secondary | Duration of Surgery | Intention-to-treat analysis set | Posted | Mean | Standard Deviation | minutes | intraoperatively (up to 3 hours) | nostrils | nostrils |
|
|
|
|
| Secondary | Number of Extra Pledgets Used | A pledget is a small wad of absorbent material used to stop bleeding. | Intention-to-treat analysis set | Posted | Mean | Standard Deviation | pledgets | intraoperatively (up to 3 hours) | nostrils | nostrils |
|
|
|
|
| Secondary | Estimated Blood Loss During Surgery | Intention-to-treat analysis set | Posted | Mean | Standard Deviation | mL | intraoperatively (up to 3 hours) | nostrils | nostrils |
|
|
|
| Secondary | Postoperative Bloody Discharge Grading Score | 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). | Intention-to-treat analysis set | Posted | Mean | Standard Deviation | score on a scale | 1 week after the surgery (up to 2 minutes to complete assessment) | nostrils | nostrils |
|
|
|
|
| Secondary | Number of Days With Postoperative Bloody Nasal Discharge | Participants indicated number of days with bloody nasal discharge postoperatively using the 1-week postoperative bleeding questionnaire. | Intention-to-treat analysis set | Posted | Mean | Standard Deviation | days | 1 week after the surgery (up to 2 minutes to complete assessment) | nostrils | nostrils |
|
|
|
|
| Secondary | Number of Nostrils With Continuous Fresh Bleeding | 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. | Intention-to-treat analysis set | Posted | Count of Units | nostrils | 1 week after the surgery (up to 2 minutes to complete assessment) | nostrils | nostrils |
|
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | 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. | 0 | 40 | 0 | 40 | 0 | 40 |
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| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |