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Phenylephrine Versus Tranexamic Acid to Control Bleeding in Patients Undergoing Inferior Turbinoplasty by Coblation

Primary Purpose

Intraoperative Bleeding, Coblation Turbinoplasty

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Topical Phenylephrine Solution
intravenous tranexamic acid
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraoperative Bleeding

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I and II Scheduled patients for Coblation Turbinoplasty surgery with inferior turbinate hypertrophy Exclusion Criteria: Known allergy to study drugs. History of coagulopathy or bleeding disorders. Patients with hypertension or ischemic heart disease. patients on anticoagulants, antiplatelets or NSAIDs history of deep vein thrombosis, stroke or peripheral vascular disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    phenylephrine

    tranexamic acid

    Arm Description

    phenylephrine-soaked pack will be applied after induction of surgery and intubation.

    Single intravenous dose of tranexamic acid 15 mg/kg will be given in 100 mL normal saline over 10 minutes.

    Outcomes

    Primary Outcome Measures

    surgical field scale
    the intraoperative surgical site bleeding using the surgical field scale as follows: 0 = No bleeding = Minimal bleeding: Not a surgical nuisance and no suction required = Mild bleeding: Occasional suction required, but does not affect dissection = Moderate bleeding: Slightly compromises surgical field, frequent suction required = Severe bleeding: Significantly compromises surgical field, frequent suction required, bleeding threat field just after removal of suction = Massive bleeding: Prevent dissection.

    Secondary Outcome Measures

    Volume of Blood loss
    Duration of surgery
    Avoidance of postoperative nasal packing
    if the patient can be spared from postoperatiove nasal pack inserted for controllling bleeding
    Intra-operative and Postoperative complications
    Complications such as nausea, vomiting, hypotnsion, hypertension, hemorraghic or thrombotic manifestations for 24 hours

    Full Information

    First Posted
    April 11, 2023
    Last Updated
    April 22, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05841251
    Brief Title
    Phenylephrine Versus Tranexamic Acid to Control Bleeding in Patients Undergoing Inferior Turbinoplasty by Coblation
    Official Title
    Phenylephrine Versus Tranexamic Acid to Control Bleeding in Patients Undergoing Inferior Turbinoplasty by Coblation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2023 (Anticipated)
    Study Completion Date
    December 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Coblation is a unique method of delivering radio frequency energy to the soft tissue for applications in otolaryngology. It induces reduction of the inferior turbinate by vaporizing and destroying the soft erectile tissue. The volume reduction and tissue fibrosis are immediate and sustainable. Bleeding from the vascular capillary beds of the sinonasal mucosa compromises the surgical field and increases operative time and risk of complications. In this study we try to assist hemostasis with a multifaceted approach, including use of topical vasoconstrictors "phenylephrine" and systemic antifibrinolytic agent "tranexamic acid".

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intraoperative Bleeding, Coblation Turbinoplasty

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    phenylephrine
    Arm Type
    Active Comparator
    Arm Description
    phenylephrine-soaked pack will be applied after induction of surgery and intubation.
    Arm Title
    tranexamic acid
    Arm Type
    Active Comparator
    Arm Description
    Single intravenous dose of tranexamic acid 15 mg/kg will be given in 100 mL normal saline over 10 minutes.
    Intervention Type
    Drug
    Intervention Name(s)
    Topical Phenylephrine Solution
    Intervention Description
    phenylephrine-soaked pack using the whole 5 ml of the solution provided with.5% phenylephrine will be applied after induction of surgery and intubation, 15 minutes before surgery. 100 ml of normal saline will be given.
    Intervention Type
    Drug
    Intervention Name(s)
    intravenous tranexamic acid
    Intervention Description
    patients will receive intravenous Single dose of tranexamic acid 15 mg/kg in 100 mL normal saline over 10 minutes. Saline-soaked pack will be applied.
    Primary Outcome Measure Information:
    Title
    surgical field scale
    Description
    the intraoperative surgical site bleeding using the surgical field scale as follows: 0 = No bleeding = Minimal bleeding: Not a surgical nuisance and no suction required = Mild bleeding: Occasional suction required, but does not affect dissection = Moderate bleeding: Slightly compromises surgical field, frequent suction required = Severe bleeding: Significantly compromises surgical field, frequent suction required, bleeding threat field just after removal of suction = Massive bleeding: Prevent dissection.
    Time Frame
    intraoperativel
    Secondary Outcome Measure Information:
    Title
    Volume of Blood loss
    Time Frame
    intraoperative
    Title
    Duration of surgery
    Time Frame
    the duration from induction of anesthesia till extubation
    Title
    Avoidance of postoperative nasal packing
    Description
    if the patient can be spared from postoperatiove nasal pack inserted for controllling bleeding
    Time Frame
    immediately after the surgey
    Title
    Intra-operative and Postoperative complications
    Description
    Complications such as nausea, vomiting, hypotnsion, hypertension, hemorraghic or thrombotic manifestations for 24 hours
    Time Frame
    intraoperative and 24 hours postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I and II Scheduled patients for Coblation Turbinoplasty surgery with inferior turbinate hypertrophy Exclusion Criteria: Known allergy to study drugs. History of coagulopathy or bleeding disorders. Patients with hypertension or ischemic heart disease. patients on anticoagulants, antiplatelets or NSAIDs history of deep vein thrombosis, stroke or peripheral vascular disease.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed A Mohammed, M.D.
    Phone
    01060757593
    Email
    ahmedfotoh86@aun.edu.eg

    12. IPD Sharing Statement

    Learn more about this trial

    Phenylephrine Versus Tranexamic Acid to Control Bleeding in Patients Undergoing Inferior Turbinoplasty by Coblation

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