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Efficacy of Oral Verapamil and Oral Diltiazim on Reduction of Intraoperative Bleeding During Endoscopic Sinus Surgery Under General Anesthesia

Primary Purpose

Verapamil, Diltiazim, FESS

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Verapamil
Diltiazem
Placebo
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Verapamil

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age of 18 - 60 years.
  • patients of both genders.
  • ASA grade I - II.

Exclusion Criteria:

  • Patient refusal.
  • Any contraindication of B- blocker:

    1. Athma , COPD
    2. Bradycardia , Heart block
    3. Acute decompensated heart failure
    4. Peripheral vascular disease
  • Any contraindication of calcium channel blocker:

    1. AV conduction defects (2nd and 3rd degree AV block).
    2. Sick sinus syndrome .
    3. Wolf-Parkinson-White Syndrome.
    4. History of congestive heart failure.
    5. Patients on long-term ß-blocker therapy.
    6. Patients with allergy to medication included in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    verapamil group

    Ditiazim

    placebo group

    Arm Description

    verapamil group who will receive verapamil 80 mg PO 3 hours preoperative

    Diltiazim group will receive Diltiazim 90mg PO 3 hours preoperative

    Placebo oral tablet

    Outcomes

    Primary Outcome Measures

    heart rate
    heart beats for minutes
    Estimated Blood Loss
    Estimated blood loss in milliliters per hour is calculated by subtracting the volume of total irrigation used during the case from the total amount of fluid in the suction canister at the end of surgery dividing by surgical time in hours.

    Secondary Outcome Measures

    The Boezaart and van der Merwe intraoperative surgical field scale.
    Boezaart Bleeding Scale (BBS) (0 - no bleeding (cadaveric conditions), 1 - Slight bleeding, no suctioning required, 2 - Slight bleeding, occasional suctioning required, 3 - Slight bleeding, frequent suctioning required; bleeding threatens surgical field a few seconds after suction is removed, 4 - Moderate bleeding, frequent suctioning required, and bleeding threatens surgical field directly after suction is removed, 5 - Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible)
    plasma norepinephrine concentrations
    plasma norepinephrine concentrations measured by enzyme immunoassay as venous blood samples about 4ml will be collected from each patient under aseptic condition
    serum cortisol concentrations
    serum cortisol will be measured by enzyme immunoassay as venous blood samples about 4ml will be collected from each patient under aseptic condition

    Full Information

    First Posted
    February 19, 2021
    Last Updated
    March 9, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04790331
    Brief Title
    Efficacy of Oral Verapamil and Oral Diltiazim on Reduction of Intraoperative Bleeding During Endoscopic Sinus Surgery Under General Anesthesia
    Official Title
    Comparative Study Between the Efficacy of Oral Verapamil and Oral Diltiazim on Reduction of Intraoperative Bleeding During Endoscopic Sinus Surgery Under General Anesthesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2021 (Anticipated)
    Primary Completion Date
    January 1, 2022 (Anticipated)
    Study Completion Date
    January 20, 2022 (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
    To study the effect of addition of oral verapamil or Diltiazim to general anaesthesia on the Intraoperative haemodynamics : heart rate(HR), noninvasive blood pressure(NIBP), mean arterial blood pressure(MAP), and the blood loss during endoscopic sinus surgery.
    Detailed Description
    Functional Endoscopic Sinus Surgery (FESS) is a minimally invasive technique used to restore sinus ventilation and function in patients with recurrent acute or chronic infective sinusitis in whom medical therapy has failed. The term FESS is used to draw attention to the potential for reestablishing natural mucociliary clearance mechanism, drainage and aeration of sinuses, and maintaining as much of the normal anatomy as possible. Over last few years this technique has become popular worldwide due to its minimally invasive nature and preservation of mucosa(1) . Intraoperative bleeding presents a larger obstacle to endoscopic visualization. Blood obscures the anatomy of the surgical field and dirties the endoscope lens leading to great difficulty in visualization (2). Continued bleeding into the surgical field during FESS not only impairs endoscopic vision , but also can lead to complications including : brain injury, orbital or optic nerve injury, and catastrophic bleeding from major vessels (e.g., internal carotid artery) (2,3). Endoscopic reconstruction with vascularized tissue is desirable to facilitate rapid healing(4). Various approaches have been used to secure a dry operating field , among them : conventional anesthesia , total intravenous anesthesia (TIVA) has been previously reported to result in reduced blood loss when used for FESS . However, few recent studies point out that (TIVA) may not significantly reduce blood loss. (5,6) One way to achieve this goal "reduction of bleeding" is to induce controlled hypotension For half a century, controlled hypotension has been used to reduce bleeding and need for blood transfusions and provide a satisfactory bloodless surgical field . Controlled hypotension is defined as a reduction of the systolic blood pressure to 80-90mm Hg,a reduction of mean arterial pressure "MAP" to 50-65mmHg or a 30% reduction of baseline "MAP"(7). Pharmacological agents used include those agents , that can be used successfully alone and those that are used adjunctively to limit dosage requirements and therefore , The adverse effects of the other agents . Agents used successfully alone include inhalation anesthetics , sodium Nitroprusside , nitroglycerin , trimethaphon camsilate , alprostadil (prostaglandin E1) , adenosine , remifentanil and agents used in spinal anesthesia.Agents that can be used alone or in combination include :Calcium Channel antagonists ( e.g nicardipine) , beta adrenoceptor - antagonists ( beta-blockers ) e.g bisoprolol , propranolol , esmolol ) and fenoldopam. Agents that are mainly used adjunctively include ACE Inhibitors , and clonidine . The definition of the ideal hypotensive agent is : It must be easy to administer , have a short onset time , an effect that disappears quickly when administration is discontinued , a rapid elimination without toxic metabolites , negligible effects on vital organs and a predictable and dose dependent effect. New agents and techniques have been recently evaluated for their ability to induce effective hypotension without impairing the perfusion of vital organs .(7,8,9) Calcium channel blockers are drugs that block the entry of calcium into the muscle cells of the heart and arteries. Thus, by blocking the entry of calcium, calcium channel blockers reduce electrical conduction within the heart, decrease the force of contraction (work) of the muscle cells, and dilate arteries which reduces blood pressure and thereby the effort the heart must exert to pump blood(10) . Although calcium channel blockers have a similar mechanism of action, they differ in their ability to affect heart muscle vs. arteries, and they differ in their ability to affect heart rate and contraction. For example; verapamil (Covera-HS, Verelan PM, Calan , Isoptin) and diltiazim( cardizem , dilacor , tiazac , diltiaxl ), reduces the strength and rate of the heart's contraction and are used in treating abnormal heart rhythms(10

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Verapamil, Diltiazim, FESS

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    135 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    verapamil group
    Arm Type
    Experimental
    Arm Description
    verapamil group who will receive verapamil 80 mg PO 3 hours preoperative
    Arm Title
    Ditiazim
    Arm Type
    Experimental
    Arm Description
    Diltiazim group will receive Diltiazim 90mg PO 3 hours preoperative
    Arm Title
    placebo group
    Arm Type
    Experimental
    Arm Description
    Placebo oral tablet
    Intervention Type
    Drug
    Intervention Name(s)
    Verapamil
    Other Intervention Name(s)
    Isoptin
    Intervention Description
    Verapamil is a phenylalkylamine calcium channel blocker used in the treatment of high blood pressure, heart arrhythmias, and angina
    Intervention Type
    Drug
    Intervention Name(s)
    Diltiazem
    Intervention Description
    Diltiazem is a calcium channel blocker. It works by relaxing the muscles of your heart and blood vessels. Diltiazem is used to treat hypertension and angina.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo oral tablet
    Primary Outcome Measure Information:
    Title
    heart rate
    Description
    heart beats for minutes
    Time Frame
    for the duration of surgery up to 2 hours
    Title
    Estimated Blood Loss
    Description
    Estimated blood loss in milliliters per hour is calculated by subtracting the volume of total irrigation used during the case from the total amount of fluid in the suction canister at the end of surgery dividing by surgical time in hours.
    Time Frame
    for the duration of surgery up to 2 hours
    Secondary Outcome Measure Information:
    Title
    The Boezaart and van der Merwe intraoperative surgical field scale.
    Description
    Boezaart Bleeding Scale (BBS) (0 - no bleeding (cadaveric conditions), 1 - Slight bleeding, no suctioning required, 2 - Slight bleeding, occasional suctioning required, 3 - Slight bleeding, frequent suctioning required; bleeding threatens surgical field a few seconds after suction is removed, 4 - Moderate bleeding, frequent suctioning required, and bleeding threatens surgical field directly after suction is removed, 5 - Severe bleeding, constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery usually not possible)
    Time Frame
    for the duration of surgery up to 2 hours
    Title
    plasma norepinephrine concentrations
    Description
    plasma norepinephrine concentrations measured by enzyme immunoassay as venous blood samples about 4ml will be collected from each patient under aseptic condition
    Time Frame
    baseline before anesthesia ( in the holding area with insertion of I.V. cannula) and three hours after the end of surgery.
    Title
    serum cortisol concentrations
    Description
    serum cortisol will be measured by enzyme immunoassay as venous blood samples about 4ml will be collected from each patient under aseptic condition
    Time Frame
    baseline before anesthesia ( in the holding area with insertion of I.V. cannula) and three hours after the end of surgery.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age of 18 - 60 years. patients of both genders. ASA grade I - II. Exclusion Criteria: Patient refusal. Any contraindication of B- blocker: Athma , COPD Bradycardia , Heart block Acute decompensated heart failure Peripheral vascular disease Any contraindication of calcium channel blocker: AV conduction defects (2nd and 3rd degree AV block). Sick sinus syndrome . Wolf-Parkinson-White Syndrome. History of congestive heart failure. Patients on long-term ß-blocker therapy. Patients with allergy to medication included in the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Peter Maher Zaki Habeeb
    Phone
    00201068058088
    Email
    pmaher1975@gmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23844295
    Citation
    Thongrong C, Kasemsiri P, Carrau RL, Bergese SD. Control of bleeding in endoscopic skull base surgery: current concepts to improve hemostasis. ISRN Surg. 2013 Jun 13;2013:191543. doi: 10.1155/2013/191543. Print 2013.
    Results Reference
    background
    PubMed Identifier
    17003708
    Citation
    Hadad G, Bassagasteguy L, Carrau RL, Mataza JC, Kassam A, Snyderman CH, Mintz A. A novel reconstructive technique after endoscopic expanded endonasal approaches: vascular pedicle nasoseptal flap. Laryngoscope. 2006 Oct;116(10):1882-6. doi: 10.1097/01.mlg.0000234933.37779.e4.
    Results Reference
    background
    PubMed Identifier
    3083327
    Citation
    Stammberger H. Endoscopic endonasal surgery--concepts in treatment of recurring rhinosinusitis. Part II. Surgical technique. Otolaryngol Head Neck Surg. 1986 Feb;94(2):147-56. doi: 10.1177/019459988609400203.
    Results Reference
    background
    PubMed Identifier
    22086769
    Citation
    Stankiewicz JA, Lal D, Connor M, Welch K. Complications in endoscopic sinus surgery for chronic rhinosinusitis: a 25-year experience. Laryngoscope. 2011 Dec;121(12):2684-701. doi: 10.1002/lary.21446. Epub 2011 Nov 15.
    Results Reference
    background
    PubMed Identifier
    12897561
    Citation
    Eberhart LH, Folz BJ, Wulf H, Geldner G. Intravenous anesthesia provides optimal surgical conditions during microscopic and endoscopic sinus surgery. Laryngoscope. 2003 Aug;113(8):1369-73. doi: 10.1097/00005537-200308000-00019.
    Results Reference
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    PubMed Identifier
    21897501
    Citation
    Ankichetty SP, Ponniah M, Cherian V, Thomas S, Kumar K, Jeslin L, Jeyasheela K, Malhotra N. Comparison of total intravenous anesthesia using propofol and inhalational anesthesia using isoflurane for controlled hypotension in functional endoscopic sinus surgery. J Anaesthesiol Clin Pharmacol. 2011 Jul;27(3):328-32. doi: 10.4103/0970-9185.83675.
    Results Reference
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    PubMed Identifier
    11212044
    Citation
    Degoute CS, Ray MJ, Manchon M, Dubreuil C, Banssillon V. Remifentanil and controlled hypotension; comparison with nitroprusside or esmolol during tympanoplasty. Can J Anaesth. 2001 Jan;48(1):20-7. doi: 10.1007/BF03019809.
    Results Reference
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    PubMed Identifier
    12083972
    Citation
    Tobias JD. Controlled hypotension in children: a critical review of available agents. Paediatr Drugs. 2002;4(7):439-53. doi: 10.2165/00128072-200204070-00003.
    Results Reference
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    PubMed Identifier
    17488147
    Citation
    Degoute CS. Controlled hypotension: a guide to drug choice. Drugs. 2007;67(7):1053-76. doi: 10.2165/00003495-200767070-00007.
    Results Reference
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