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Comparative Study Between the Efficacy of Verapamil and Bisoprolol on Reduction of Bleeding During Endoscopic Sinus Surgery Under General Anaesthesia.

Primary Purpose

Endoscopic Sinus Surgery, Heart Rate, Blood Loss

Status
Active
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Verapamil
Bisoprolol
Placebo oral tablet
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Endoscopic Sinus Surgery

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

  • Faculty of medicine Assiut university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Verapamil group

Bisoprolol group

placebo group

Arm Description

45 patients will receive 80 mg oral verapamil 3 hours pre-operative

45 patients will receive Bisoprolol 5mg PO 3 hours preoperative

45 patients will receive placebo tablet PO 3 hours preoperative .

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
April 18, 2020
Last Updated
November 21, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04356196
Brief Title
Comparative Study Between the Efficacy of Verapamil and Bisoprolol on Reduction of Bleeding During Endoscopic Sinus Surgery Under General Anaesthesia.
Official Title
Comparative Study Between the Efficacy of Verapamil and Bisoprolol on Reduction of Bleeding During Endoscopic Sinus Surgery Under General Anaesthesia.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
December 28, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (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 study aims to compare the effect of addition of verapamil and Bisoprolol to general anasthesia aimed reduction in heart rate and blood loss during endoscopic sinus surgery.
Detailed Description
Intra-operative bleeding presents a larger obstacle to endoscopic visualization. Blood obscures the anatomy of the surgical field and dirties the endoscope lens causing greater difficulty with visualization. This situation increases the risk of complications, including brain injury, orbital or optic nerve injury, and catastrophic bleeding from major vessels (e.g., internal carotid artery) 1. Endoscopic sinus surgery (ESS) 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 ESS is used to draw attention to the potential for reestablishing natural mucociliary clearance mechanism, drainage and aeration of sinuses, whilst 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 mucosa2. Continued bleeding into the surgical field during ESS not only impairs endoscopic vision but can lead to complications3. Compared with 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 4-5. Controlled hypotension has been used to reduce bleeding and the need for blood transfusions, and provide a satisfactory bloodless surgical field . Controlled hypotension is defined as a reduction of the systolic blood pressure to 80-90 mm Hg, a reduction of mean arterial pressure (MAP) to 50-65 mm Hg or a 30% reduction of baseline MAP 6. 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 7 . Pharmacological agents used for controlled hypotension 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 anaesthetics, sodium nitroprusside, nitroglycerin, trimethaphan camsilate, alprostadil (prostaglandin E1), adenosine, remifentanil, and agents used in spinal anaesthesia. Agents that can be used alone or in combination include calcium channel antagonists (e.g. nicardipine), beta-adrenoceptor antagonists (beta- blockers) [e.g. bisoprolo, propranolol, esmolol] and fenoldopam. Agents that are mainly used adjunctively include ACE inhibitors and clonidine. New agents and techniques have been recently evaluated for their ability to induce effective hypotension without impairing the perfusion of vital organs 8. 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 9. 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), reduces the strength and rate of the heart's contraction and are used in treating abnormal heart rhythms10. Beta-blockers antagonise the effects of sympathetic nerve stimulation or circulating catecholamines at beta-adrenoceptors which are widely distributed throughout body systems. Beta1-receptors are predominant in the heart (and kidney) while beta2- receptors are predominant in other organs such as the lung, peripheral blood vessels and skeletal muscle11.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endoscopic Sinus Surgery, Heart Rate, Blood Loss

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Verapamil group
Arm Type
Experimental
Arm Description
45 patients will receive 80 mg oral verapamil 3 hours pre-operative
Arm Title
Bisoprolol group
Arm Type
Experimental
Arm Description
45 patients will receive Bisoprolol 5mg PO 3 hours preoperative
Arm Title
placebo group
Arm Type
Experimental
Arm Description
45 patients will receive placebo tablet PO 3 hours preoperative .
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)
Bisoprolol
Other Intervention Name(s)
concor
Intervention Description
Bisoprolol is a cardioselective β1-adrenergic blocking agent used to treat high blood pressure.
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
Placebo oral tablet
Primary Outcome Measure Information:
Title
Heart Rate
Description
heart beats for minutes
Time Frame
intraoperative
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
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 Anastasia ( 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 Anastasia ( 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Sayed Hassanein
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine Assiut university
City
Assiut
Country
Egypt

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
background
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
background
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
background
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
background
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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Comparative Study Between the Efficacy of Verapamil and Bisoprolol on Reduction of Bleeding During Endoscopic Sinus Surgery Under General Anaesthesia.

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