Clinical trial NCT05867342: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intraoperative Bleeding
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Surgical Field Grading Score
timeFrame: postoperatively (approximately 20 minutes to assess)
Secondary outcomes:
measure: Duration of Surgery
timeFrame: intraoperatively (up to 3 hours)
measure: Number of Extra Pledgets Used
timeFrame: intraoperatively (up to 3 hours)
measure: Estimated Blood Loss During Surgery
timeFrame: intraoperatively (up to 3 hours)
measure: Postoperative Bloody Discharge Grading Score
timeFrame: 1 week after the surgery (up to 2 minutes to complete assessment)
measure: Number of Days With Postoperative Bloody Nasal Discharge
timeFrame: 1 week after the surgery (up to 2 minutes to complete assessment)
measure: Number of Nostrils With Continuous Fresh Bleeding
timeFrame: 1 week after the surgery (up to 2 minutes to complete assessment)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford
state: California
Study officials:
affiliation: Stanford University
name: Peter H Hwang, MD
role: STUDY_DIRECTOR
affiliation: Stanford University
name: Navarat Tangbumrungtham, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.