Back to resultsEffects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery
Primary Purpose
Intraoperative Bleeding
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Epinephrin
1% lidocaine with epinephrin 1:100,000
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Intraoperative Bleeding
Eligibility Criteria
Inclusion Criteria: Diagnosed with recurrent acute or chronic rhinosinusitis recalcitrant to medical treatment and scheduled for endoscopic sinus surgery Exclusion Criteria: Patients who have asymetrical disease on the two sides (Lund Mackay score difference more than 2) Patients who have endoscopic sinus surgery for treatment of tumor or disease other than sinusitis Patients with underlying uncontrolled hypertension Patients with bleeding disorder or are unable to discontinue antiplatelet or anticoagulant before the surgery Patients who are allergic to adrenaline or to xylocaine
Sites / Locations
- Stanford
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endoscopic sinus surgery
Arm Description
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).
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Duration of Surgery
Number of Extra Pledgets Used
A pledget is a small wad of absorbent material used to stop bleeding.
Estimated Blood Loss During Surgery
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).
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05867342
Brief Title
Effects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery
Official Title
Effects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 12, 2017 (Actual)
Primary Completion Date
August 22, 2018 (Actual)
Study Completion Date
August 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endoscopic sinus surgery
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Epinephrin
Other Intervention Name(s)
Adrenaline
Intervention Description
Topical application of 2 pieces of Epinephrin (1:1,000)-soaked cottonoid in nasal cavity
Intervention Type
Drug
Intervention Name(s)
1% lidocaine with epinephrin 1:100,000
Intervention Description
4 ml intranasal infiltration of 1% lidocaine with epinephrine (1:100,000) at 2 sites (2 ml infiltration at each site)
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
4 ml intranasal infiltration of saline at 2 sites (2 ml infiltration at each site)
Primary Outcome Measure Information:
Title
Surgical Field Grading Score
Description
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).
Time Frame
postoperatively (approximately 20 minutes to assess)
Secondary Outcome Measure Information:
Title
Duration of Surgery
Time Frame
intraoperatively (up to 3 hours)
Title
Number of Extra Pledgets Used
Description
A pledget is a small wad of absorbent material used to stop bleeding.
Time Frame
intraoperatively (up to 3 hours)
Title
Estimated Blood Loss During Surgery
Time Frame
intraoperatively (up to 3 hours)
Title
Postoperative Bloody Discharge Grading Score
Description
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).
Time Frame
1 week after the surgery (up to 2 minutes to complete assessment)
Title
Number of Days With Postoperative Bloody Nasal Discharge
Description
Participants indicated number of days with bloody nasal discharge postoperatively using the 1-week postoperative bleeding questionnaire.
Time Frame
1 week after the surgery (up to 2 minutes to complete assessment)
Title
Number of Nostrils With Continuous Fresh Bleeding
Description
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.
Time Frame
1 week after the surgery (up to 2 minutes to complete assessment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with recurrent acute or chronic rhinosinusitis recalcitrant to medical treatment and scheduled for endoscopic sinus surgery
Exclusion Criteria:
Patients who have asymetrical disease on the two sides (Lund Mackay score difference more than 2)
Patients who have endoscopic sinus surgery for treatment of tumor or disease other than sinusitis
Patients with underlying uncontrolled hypertension
Patients with bleeding disorder or are unable to discontinue antiplatelet or anticoagulant before the surgery
Patients who are allergic to adrenaline or to xylocaine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter H Hwang, MD
Organizational Affiliation
Stanford University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Navarat Tangbumrungtham, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26452438
Citation
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.
Results Reference
background
PubMed Identifier
16959188
Citation
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.
Results Reference
background
PubMed Identifier
16223392
Citation
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.
Results Reference
background
PubMed Identifier
19841339
Citation
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.
Results Reference
background
PubMed Identifier
23255493
Citation
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.
Results Reference
background
PubMed Identifier
18438267
Citation
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.
Results Reference
background
PubMed Identifier
31671251
Citation
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.
Results Reference
result
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Effects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery
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