Effects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery

Intraoperative Bleeding Clinical Trial

Official title:

Effects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05867342
• Other study ID #: 40274
• Status: Completed
• Phase: Phase 4
• Start date: May 12, 2017
• Est. completion date: August 22, 2018

Study information

• Verified date: June 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 22, 2018
• Est. primary completion date: August 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Intraoperative Bleeding

Intervention

Drug:
• Epinephrin
Topical application of 2 pieces of Epinephrin (1:1,000)-soaked cottonoid in nasal cavity
• 1% lidocaine with epinephrin 1:100,000
4 ml intranasal infiltration of 1% lidocaine with epinephrine (1:100,000) at 2 sites (2 ml infiltration at each site)
• Saline
4 ml intranasal infiltration of saline at 2 sites (2 ml infiltration at each site)

Locations

Country	Name	City	State
United States	Stanford	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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 dou — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	postoperatively (approximately 20 minutes to assess)
Secondary	Duration of Surgery		intraoperatively (up to 3 hours)
Secondary	Number of Extra Pledgets Used	A pledget is a small wad of absorbent material used to stop bleeding.	intraoperatively (up to 3 hours)
Secondary	Estimated Blood Loss During Surgery		intraoperatively (up to 3 hours)
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).	1 week after the surgery (up to 2 minutes to complete assessment)
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.	1 week after the surgery (up to 2 minutes to complete assessment)
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.	1 week after the surgery (up to 2 minutes to complete assessment)