Effects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery
- Registration Number
- NCT05867342
- Lead Sponsor
- Stanford University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Diagnosed with recurrent acute or chronic rhinosinusitis recalcitrant to medical treatment and scheduled for endoscopic sinus surgery
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Endoscopic sinus surgery 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). Endoscopic sinus surgery Epinephrin 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).
- Primary Outcome Measures
Name Time Method Surgical Field Grading Score postoperatively (approximately 20 minutes to assess) 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
Name Time Method Duration of Surgery intraoperatively (up to 3 hours) Postoperative Bloody Discharge Grading Score 1 week after the surgery (up to 2 minutes to complete assessment) 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).
Estimated Blood Loss During Surgery intraoperatively (up to 3 hours) Number of Extra Pledgets Used intraoperatively (up to 3 hours) A pledget is a small wad of absorbent material used to stop bleeding.
Number of Days With Postoperative Bloody Nasal Discharge 1 week after the surgery (up to 2 minutes to complete assessment) Participants indicated number of days with bloody nasal discharge postoperatively using the 1-week postoperative bleeding questionnaire.
Number of Nostrils With Continuous Fresh Bleeding 1 week after the surgery (up to 2 minutes to complete assessment) 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.
Trial Locations
- Locations (1)
Stanford
🇺🇸Stanford, California, United States