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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
Jordan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

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

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 23, 2020
    Last Updated
    September 15, 2020
    Sponsor
    Jordan University of Science and Technology
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    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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