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Efficacy of Oral Diltiazem on the Intraoperative Bleeding in Functional Endoscopic Sinus Surgery

Primary Purpose

Hypotension on Induction

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
oral Diltiazem
IV Tranexamic Acid
Placebo Oral Tablet
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension on Induction

Eligibility Criteria

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

Inclusion Criteria:

include patients who undergoing elective FESS under general anesthesia and meet these criteria:

- Age from 18 - 60 years old. - ASA grade I - II.

Exclusion Criteria:

  • - Patient refusal.
  • 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.
  • Patients with allergy to medication included in the study.
  • Any contraindication of Tranexamic Acid:

    1. bleeding disorders.
    2. pregnant or breastfeeding mothers.
    3. patient under the influence of anticoagulants.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    1st group

    2nd group

    3rd group

    Arm Description

    20 patients will receive 90 mg oral Diltiazem 3 hours pre-operative

    20 patients will receive 90 mg oral Diltiazem 3 hours pre-operative+ 10 mg/kg IV Tranexamic Acid slow infusion with saline half an hour before the induction of anesthesia

    20 patients will receive oral placebo tablet 3 hours pre-operative

    Outcomes

    Primary Outcome Measures

    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).
    Incidence of hypotension
    systolic blood pressure values are 80-90mmHg Mean arterial pressure is reduced to 50-65mmHg
    total consumption of propofol
    The investigators will measure the consumption of propofol intraoperatively
    Heart Rate
    heart beats for minutes
    End Tidal CO2
    The concentration of carbon dioxide (CO2) in the respiratory gases

    Full Information

    First Posted
    June 12, 2018
    Last Updated
    June 26, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03580590
    Brief Title
    Efficacy of Oral Diltiazem on the Intraoperative Bleeding in Functional Endoscopic Sinus Surgery
    Official Title
    Efficacy of Oral Diltiazem Versus Combination of Oral Diltiazem With Intravenous Tranexamic Acid on the Intraoperative Bleeding in Functional Endoscopic Sinus Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2018 (Anticipated)
    Primary Completion Date
    November 1, 2019 (Anticipated)
    Study Completion Date
    January 1, 2020 (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
    The primary endpoint is the effect of the addition of oral Diltiazem and Tranexamic Acid to general anesthesia aided reduction in blood loss during functional endoscopic sinus surgery (FESS). The secondary endpoint is surgeon's assessment of the surgical field and hemodynamics.
    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. Continued bleeding into the surgical field during FESS not only impairs endoscopic vision but can lead to complications. Controlled hypotension is a technique used to limit intraoperative blood loss to provide the best possible field for surgery. The physiological principle which underlies hypotensive anesthesia is a natural survival mechanism. When profuse bleeding occurs, the blood pressure drops. This drop leads to a reduction or cessation of the bleeding, blood pressure stabilization, and recovery. Accordingly, reducing the patient's blood pressure during surgery can potentially reduce overall bleeding. Since bleeding in the surgical field is also reduced, the surgical field operating conditions are improved In hypotensive anesthesia, the patient's baseline mean arterial pressure (MAP) is reduced by 30 %. Consequently, the systolic blood pressure values are about 80-90mmHg and the MAP is reduced to 50- 65mmHg. Hypotensive anesthesia is considered to be a suitable anesthetic technique for those patients who will be undergoing spinal surgery, hip or knee arthroplasty, craniosynostosis, hepatic resections, and major maxillofacial operations. Benefits for controlled hypotension for FESS include the reduction in blood loss with improved quality of the surgical field. Various agent's anesthetic agents, analgesics, and hypotensive drugs, that have been used for achieving hypotensive anesthesia: Volatile Anesthetic Agents. Most anesthetic agents have a hypotensive effect such as isoflurane, sevoflurane, and desflurane, high concentrations are required to achieve a significant reduction in intraoperative bleeding, and these concentrations may lead to hepatic or renal injury. Propofol. has a potent hypotensive capability, but normal blood pressure will be rapidly restored when the propofol infusion is discontinued. Although a short-term propofol infusion is safe, a long-term Propofol infusion can cause propofol infusion syndrome in children. Alfentanil, Sufentanil, and Remifentanil. potent synthetic and short-acting opioid drugs, Since the recovery times from this type of anesthesia are also short, they are widely used for hypotensive anesthesia. d.Nitrates. SNP and NTG are two very potent hypotensive agents that are commonly used for inducing hypotensive anesthesia. Reflex tachycardia is an unwanted effect which often occurs with nitrates administration and can be prevented by a small dose of the beta-adrenoceptor antagonist, such as esmolol or propranolol premedication. e-beta-Adrenoceptor Antagonists. They effectively used for inducing hypotensive anesthesia when administered either as a single hypotensive agent or in combination with SNP. Nonselective beta-antagonists, such as labetalol, may cause bronchoconstriction and should be avoided in asthmatic patients. The hypotensive action of beta-adrenoceptor antagonists is achieved by reducing cardiac output. So, not suitable for the patient with underlying heart failure. f-Calcium Channel Antagonists. such as nifedipine or nicardipine, are commonly used as hypotensive drugs. Diltiazem, a calcium channel blocker, blocks the influx of calcium into smooth muscle cells and cardiac muscle cells. This causes relaxation of the muscle, thereby causing reduced arteriolar tone and fall in blood pressure. Tranexamic acid is a synthetic amino acid that inhibits fibrinolysis, which reduces blood loss and the need for blood transfusion in total knee arthroplasty, spine surgery, and cardiac surgery. It has seen wide application in a variety of surgical procedures since then.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypotension on Induction

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1st group
    Arm Type
    Experimental
    Arm Description
    20 patients will receive 90 mg oral Diltiazem 3 hours pre-operative
    Arm Title
    2nd group
    Arm Type
    Experimental
    Arm Description
    20 patients will receive 90 mg oral Diltiazem 3 hours pre-operative+ 10 mg/kg IV Tranexamic Acid slow infusion with saline half an hour before the induction of anesthesia
    Arm Title
    3rd group
    Arm Type
    Placebo Comparator
    Arm Description
    20 patients will receive oral placebo tablet 3 hours pre-operative
    Intervention Type
    Drug
    Intervention Name(s)
    oral Diltiazem
    Other Intervention Name(s)
    diltiazem
    Intervention Description
    Diltiazem, a calcium channel blocker reduced arteriolar tone and fall in blood pressure
    Intervention Type
    Drug
    Intervention Name(s)
    IV Tranexamic Acid
    Other Intervention Name(s)
    capron
    Intervention Description
    Tranexamic acid inhibits fibrinolysis, which reduces blood loss
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo Oral Tablet
    Intervention Description
    Placebo Oral Tablet
    Primary Outcome Measure Information:
    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
    end of operation assessment
    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
    Every 15 minutes for the duration of surgery
    Title
    Incidence of hypotension
    Description
    systolic blood pressure values are 80-90mmHg Mean arterial pressure is reduced to 50-65mmHg
    Time Frame
    Hemodynamic parameters as systolic, diastolic and mean arterial blood pressures were recorded before drug intake, before induction, after induction, intraoperative every 5 minutes till the end of surgery, every 15 minutes post operative
    Title
    total consumption of propofol
    Description
    The investigators will measure the consumption of propofol intraoperatively
    Time Frame
    end of operation assessment
    Title
    Heart Rate
    Description
    heart beats for minutes
    Time Frame
    Heart Rate recorded before drug intake, before induction, after induction, intraoperative every 5 minutes till the end of surgery, every 15 minutes postoperative
    Title
    End Tidal CO2
    Description
    The concentration of carbon dioxide (CO2) in the respiratory gases
    Time Frame
    End Tidal CO2 before induction, after induction, intraoperative every 5 minutes till 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
    No
    Eligibility Criteria
    Inclusion Criteria: include patients who undergoing elective FESS under general anesthesia and meet these criteria: - Age from 18 - 60 years old. - ASA grade I - II. Exclusion Criteria: - Patient refusal. 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. Any contraindication of Tranexamic Acid: bleeding disorders. pregnant or breastfeeding mothers. patient under the influence of anticoagulants.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Moutaz Ismail, MD
    Phone
    01061844619
    Ext
    +2
    Email
    dr.moetaz89@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amany Hassan Abd ElWahab, PhD
    Phone
    01004610623
    Ext
    +2
    Email
    amanihassan1976@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hamdy Abbas Youssef, PhD
    Organizational Affiliation
    Assiut Univerity
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27687369
    Citation
    Aravindan A, Subramanium R, Chhabra A, Datta PK, Rewari V, Sharma SC, Kumar R. Magnesium sulfate or diltiazem as adjuvants to total intravenous anesthesia to reduce blood loss in functional endoscopic sinus surgery. J Clin Anesth. 2016 Nov;34:179-85. doi: 10.1016/j.jclinane.2016.03.068. Epub 2016 May 10.
    Results Reference
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    Efficacy of Oral Diltiazem on the Intraoperative Bleeding in Functional Endoscopic Sinus Surgery

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