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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03580590
Recruitment Status : Not yet recruiting
First Posted : July 9, 2018
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
Moutaz Ragab Ismail Ibrahim, Assiut University

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.

Condition or disease Intervention/treatment Phase
Hypotension on Induction Drug: oral Diltiazem Drug: IV Tranexamic Acid Drug: Placebo Oral Tablet Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Oral Diltiazem Versus Combination of Oral Diltiazem With Intravenous Tranexamic Acid on the Intraoperative Bleeding in Functional Endoscopic Sinus Surgery
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1st group
20 patients will receive 90 mg oral Diltiazem 3 hours pre-operative
Drug: oral Diltiazem
Diltiazem, a calcium channel blocker reduced arteriolar tone and fall in blood pressure
Other Name: diltiazem

Experimental: 2nd group
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
Drug: oral Diltiazem
Diltiazem, a calcium channel blocker reduced arteriolar tone and fall in blood pressure
Other Name: diltiazem

Drug: IV Tranexamic Acid
Tranexamic acid inhibits fibrinolysis, which reduces blood loss
Other Name: capron

Placebo Comparator: 3rd group
20 patients will receive oral placebo tablet 3 hours pre-operative
Drug: Placebo Oral Tablet
Placebo Oral Tablet




Primary Outcome Measures :
  1. Estimated Blood Loss [ Time Frame: end of operation assessment ]
    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 :
  1. The Boezaart and van der Merwe intraoperative surgical field scale [ Time Frame: Every 15 minutes for the duration of surgery ]
    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).

  2. Incidence of hypotension [ 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 ]
    systolic blood pressure values are 80-90mmHg Mean arterial pressure is reduced to 50-65mmHg

  3. total consumption of propofol [ Time Frame: end of operation assessment ]
    The investigators will measure the consumption of propofol intraoperatively

  4. Heart Rate [ 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 ]
    heart beats for minutes

  5. End Tidal CO2 [ Time Frame: End Tidal CO2 before induction, after induction, intraoperative every 5 minutes till the end of surgery ]
    The concentration of carbon dioxide (CO2) in the respiratory gases



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580590


Contacts
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Contact: Moutaz Ismail, MD 01061844619 ext +2 dr.moetaz89@gmail.com
Contact: Amany Hassan Abd ElWahab, PhD 01004610623 ext +2 amanihassan1976@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Hamdy Abbas Youssef, PhD Assiut Univerity

Publications:
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Responsible Party: Moutaz Ragab Ismail Ibrahim, M.D, Assiut University
ClinicalTrials.gov Identifier: NCT03580590    
Other Study ID Numbers: Oral diltiazem in FESS
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypotension
Blood Loss, Surgical
Hemorrhage
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Intraoperative Complications
Diltiazem
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents