Adrenaline Solution Irrigation and Bleeding During Sinus Surgery

NCT04551703 | Completed Phase 1

• 1 other identifier: 221
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Intranasal irrigation with normal saline is routinely used in sinus surgery to clean the tip of the nasal endoscope and clear the surgical field from blood. The purpose of this study is to evaluate the difference in the surgical visualization, surgeon satisfaction and total blood loss when intraoperative irrigation was performed with a solution of normal saline with adrenaline as compared to irrigation with normal saline alone in FESS.

Conditions

Chronic Rhinosinusitis (Diagnosis)

Keywords

Sinusitis; Nasal Polyp; Endoscopic Sinus Surgery; Adrenaline

Outcome Measures

Primary Outcomes (1)

• The Boezaart intraoperative surgical field scale

  The Boezaart intra-operative surgical field scale will be used to grade the level of bleeding during surgery. This 0 to 5-point scale will be used to outline the amount of suction required to rid the area of blood disrupting vision. A score of 0 is given for an area with no bleeding, 1 for slight bleeding with no suction required, 2 for slight bleeding requiring suction, 3 for moderate bleeding which improves for several seconds once suction has occurred, 4 for moderate bleeding which restarts directly after suctioning and 5 for severe bleeding which occurs faster then can be removed

  2 hours

Secondary Outcomes (1)

• Volume of total blood loss

  The volume of blood loss will be measured every 30 minutes from the start of surgery for the duration of 2 hours

Study Arms (2)

Adrenaline saline irrigation

EXPERIMENTAL

Adrenaline saline irrigation will be prepared by adding one ampule of 0.1 percent adrenaline in one liter bag of normal saline, which made the adrenaline concentration in the solution 1:100 000

Drug: Adrenaline saline irrigation

Normal saline irrigation

NO INTERVENTION

Normal saline bag will be used for irrigation during the procedure

Interventions

Adrenaline saline irrigation DRUG

The surgical field is flushed with 20 cc of Adrenaline saline irrigation. This is in contrast to the standard of care, normal saline irrigation.

Also known as: Epinephrine saline irrigation

Adrenaline saline irrigation

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with American Society of Anesthesiologist (ASA) classification \<2
• Patients with chronic with or without nasal polyposis refractory to medical treatment

You may not qualify if:

• Patients with a history of of bleeding diathesis
• Patients with severe ischemic heart disease , pulmonary and renal disease
• Patients with tumours or vascular anomalies
• Patients with cystic fibrosis, allergic fungal sinusitis and granulomatous disorders
• Patients who are unable to speak, read and write English

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Related Publications (5)

• Higgins TS, Hwang PH, Kingdom TT, Orlandi RR, Stammberger H, Han JK. Systematic review of topical vasoconstrictors in endoscopic sinus surgery. Laryngoscope. 2011 Feb;121(2):422-32. doi: 10.1002/lary.21286. Epub 2011 Jan 13.

  PMID: 21271600 RESULT

• 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 RESULT

• Yim MT, Ahmed OG, Takashima M. Evaluating real-time effects of topical 1:1000 epinephrine in endoscopic sinus and skull-base surgery on hemodynamic parameters through intraoperative arterial line monitoring. Int Forum Allergy Rhinol. 2017 Nov;7(11):1065-1069. doi: 10.1002/alr.22012. Epub 2017 Sep 18.

  PMID: 28922579 RESULT

• 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 RESULT

• Gan EC, Alsaleh S, Manji J, Habib AR, Amanian A, Javer AR. Hemostatic effect of hot saline irrigation during functional endoscopic sinus surgery: a randomized controlled trial. Int Forum Allergy Rhinol. 2014 Nov;4(11):877-84. doi: 10.1002/alr.21376. Epub 2014 Aug 18.

  PMID: 25137523 RESULT

MeSH Terms

Conditions

Disease; Sinusitis; Nasal Polyps

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical

Study Officials

• Mohannad A Al-Qudah, MD,FACS

  Jordan University of Science & Technology & King Abdullah University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will randomize into two groups based on computer generating numbers. Group 1 will have the usual method of irrigation with normal saline during surgery whereas group 2 have irrigation with 1:100 000 adrenaline in normal saline. The solution will be prepared by the senior resident through adding one ampule of 0.1 percent adrenaline in one liter bag of normal saline, which made the adrenaline concentration in the solution 1:100 000. The investigators who collected the data will be blinded to the content of both preparations. Irrigation with either solution will be used during the procedure through a 20 mL syringe attached to an olive tip long curved suction.

Study Record Dates

• First Submitted: August 23, 2020
• First Posted: September 16, 2020
• Study Start: July 1, 2016
• Primary Completion: August 11, 2020
• Study Completion: August 11, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share