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

NCT05867342 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 40274
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraoperative Bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Duration of Surgery

  intraoperatively (up to 3 hours)

• Number of Extra Pledgets Used

  intraoperatively (up to 3 hours)

• Estimated Blood Loss During Surgery

  intraoperatively (up to 3 hours)

• Postoperative Bloody Discharge Grading Score

  1 week after the surgery (up to 2 minutes to complete assessment)

• Number of Days With Postoperative Bloody Nasal Discharge

  1 week after the surgery (up to 2 minutes to complete assessment)

Study Arms (1)

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).

Drug: Epinephrin; Drug: 1% lidocaine with epinephrin 1:100,000; Drug: Saline

Interventions

Epinephrin DRUG

Topical application of 2 pieces of Epinephrin (1:1,000)-soaked cottonoid in nasal cavity

Also known as: Adrenaline

Endoscopic sinus surgery

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)

Endoscopic sinus surgery

Saline DRUG

4 ml intranasal infiltration of saline at 2 sites (2 ml infiltration at each site)

Endoscopic sinus surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with recurrent acute or chronic rhinosinusitis recalcitrant to medical treatment and scheduled for endoscopic sinus surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford

Stanford, California, 94304, United States

Location

Related Publications (7)

• 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.

  PMID: 26452438 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.

  PMID: 16959188 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.

  PMID: 16223392 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.

  PMID: 19841339 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.

  PMID: 23255493 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.

  PMID: 18438267 BACKGROUND

• 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.

  PMID: 31671251 RESULT

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Epinephrine; Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Acetanilides; Anilides; Amides; Aniline Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Peter H. Hwang, MD
• Organization: Stanford University

hwangph@stanford.edu

(650) 725-6500

Study Officials

• Peter H Hwang, MD

  Stanford University

  STUDY DIRECTOR

• Navarat Tangbumrungtham, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otolaryngology - Head & Neck Surgery (OHNS)

Study Record Dates

• First Submitted: November 22, 2018
• First Posted: May 22, 2023
• Study Start: May 12, 2017
• Primary Completion: August 22, 2018
• Study Completion: August 22, 2018
• Last Updated: July 10, 2023
• Results First Posted: July 10, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)