Adrenaline Solution Irrigation and Bleeding During Sinus Surgery
Primary Purpose
Chronic Rhinosinusitis (Diagnosis)
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Adrenaline saline irrigation
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Rhinosinusitis (Diagnosis) focused on measuring Sinusitis, Nasal Polyp, Endoscopic Sinus Surgery, Adrenaline
Eligibility Criteria
Inclusion Criteria:
- Patients with American Society of Anesthesiologist (ASA) classification <2
- Patients with chronic with or without nasal polyposis refractory to medical treatment
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Adrenaline saline irrigation
Normal saline irrigation
Arm Description
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
Normal saline bag will be used for irrigation during the procedure
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Volume of total blood loss
Total blood loss will be calculated and measured over the duration of surgery.
Full Information
NCT ID
NCT04551703
First Posted
August 23, 2020
Last Updated
September 15, 2020
Sponsor
Jordan University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT04551703
Brief Title
Adrenaline Solution Irrigation and Bleeding During Sinus Surgery
Official Title
The Effect of Intranasal Irrigation With Adrenaline Solution on Intraoperative Visualization and Bleeding During Functional Endoscopic Sinus Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
August 11, 2020 (Actual)
Study Completion Date
August 11, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jordan University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Functional Endoscopic Sinus Surgery (FESS) is a common, effective and minimally invasive surgical procedure indicated mainly to treat medically resistant chronic rhinosinusitis with or without nasal polyposis.
The surgery is often performed under general anesthesia and proceeds in anatomically based surgical landmarks steps to facilitate drainage and ventilation of the paranasal sinuses. As any other endoscopic and laparoscopic procedures the operation requires dry surgical field to ensure accurate identification and visualization of structures and smooth surgical dissection progression. Intranasal bleeding during FESS will increase time of surgery and perioperative complications. Also it could affect healing process, increase adhesion formation and lengthening recovery period .
Different methods and maneuvers have been described in the literature to reduce intra-operative bleeding during sinus surgery. These include: elevation of the patient's head, the use of bipolar cautery and powered instruments; premedication with beta blockers; a controlled hypotensive anesthesia technique; total intravenous anesthesia, topical hemostatic biomaterials and local application of vasoconstrictors.
Adrenaline is one of the most commonly used topical vasoconstrective agent. Because systemic absorption of infiltrated adrenaline can give rise to a sudden increase in blood levels of catecholamine compared to topical instillation and thus various life-threatening complications, such as : cardiac arrhythmia, cardiac arrest, cardiomyopathy, pulmonary edema, and central retinal artery occlusion; many surgeons prefer to use instillation of adrenaline over infiltration in FESS
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis (Diagnosis)
Keywords
Sinusitis, Nasal Polyp, Endoscopic Sinus Surgery, Adrenaline
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adrenaline saline irrigation
Arm Type
Experimental
Arm Description
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
Arm Title
Normal saline irrigation
Arm Type
No Intervention
Arm Description
Normal saline bag will be used for irrigation during the procedure
Intervention Type
Drug
Intervention Name(s)
Adrenaline saline irrigation
Other Intervention Name(s)
Epinephrine saline irrigation
Intervention Description
The surgical field is flushed with 20 cc of Adrenaline saline irrigation. This is in contrast to the standard of care, normal saline irrigation.
Primary Outcome Measure Information:
Title
The Boezaart intraoperative surgical field scale
Description
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
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Volume of total blood loss
Description
Total blood loss will be calculated and measured over the duration of surgery.
Time Frame
The volume of blood loss will be measured every 30 minutes from the start of surgery for the duration of 2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with American Society of Anesthesiologist (ASA) classification <2
Patients with chronic with or without nasal polyposis refractory to medical treatment
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohannad A Al-Qudah, MD,FACS
Organizational Affiliation
Jordan University of Science & Technology & King Abdullah University Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21271600
Citation
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.
Results Reference
result
PubMed Identifier
26452438
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.
Results Reference
result
PubMed Identifier
28922579
Citation
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.
Results Reference
result
PubMed Identifier
23255493
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.
Results Reference
result
PubMed Identifier
25137523
Citation
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.
Results Reference
result
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Adrenaline Solution Irrigation and Bleeding During Sinus Surgery
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