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Completed

NCT Number: NCT05430048

Nasal Desmopressin Versus Oral Bisoprolol for Controlling Bleeding During Endoscopic Sinus Surgery

Functional endoscopic sinus surgery (FESS) is well established for treatment of chronic rhinosinusitis and nasal polyps. Masking of the surgical field can lead to severe complication as tissue injury, increase post-operative adhesions and scarring and even severe orbital and brain injury In the current study we will investigate the effect of nasal desmopressin versus oral bisoprolol for controlling bleeding and improving surgical field clarity during functional endoscopic sinus surgery

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Heba M Fathi

Zagazig, Sharqia Province, Egypt

About this study

Functional endoscopic sinus surgery (FESS) is well established for treatment of chronic rhinosinusitis and nasal polyps.

The nasal mucosa at the site of surgery is very sensitive to sympathetic stimulation which Cause intraoperative hypertension and tachycardia. It is also highly vascular and can bleed easily, so Compromise the visual clarity of the surgical field. Masking of the surgical field can lead to severe complication as tissue injury, increase post-operative adhesions and scarring and even severe orbital and brain injury. Multiple techniques have been discussed to improve the surgical field in endoscopic sinus surgery, including the use of bipolar diathermy, topical vasoconstrictors, and induced hypotension, However none of them has provided optimal surgical condition.

Desmopressin (1 deamino 8 D argininevasopressin) is a synthetic analog of the antidiuretic hormone L arginine vasopressin. It was used in mild to moderate hemophilia, von Willebrand's disease, and other acquired platelet deficiencies to increases plasma concentrations of tissue plasminogen activator and endothelial factor VIII. Intravenous use was proved to decrease intraoperative bleeding during spine surgery, facial plastic surgeries, septo-rhinoplasty and FESS. Intranasal spray used effectively to reduce bleeding and improves the surgical field during FESS.

The short acting β-adrenergic receptor antagonist such as labetalol, metoprolol and esmolol have been successfully used for lowering blood pressure, decreasing bleeding and improving surgical field.

Bisoprolol, has the advantage of longer acting. Bisoprolol has a higher degree of β1-selectivity compared to other β1-selective beta blockers such as atenolol, metoprolol, and betaxolol. It was approved for medical use in the United States in 1992. Bisoprolol inhibits renin secretion by about 65% and tachycardia by about 30%.

In the current study we will investigate the effect of nasal desmopressin versus oral bisoprolol for controlling bleeding and improving surgical field clarity during functional endoscopic sinus surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients scheduled for unilateral functional endoscopic sinus surgery, aged between 21 - 60 years, both genders, ASA grade I - II and body mass index 25-30 kg/m -

Exclusion criteria

Patients with acute decompensated heart failure, Peripheral vascular disease, hypertension, heart block, Asthma, bleeding disorders, coronary disease, compromised renal or hepatic function, hyponatremia , pregnancy or history of allergy to the study drugs and those on anti-platelet, anticoagulant or B blocker drugs.

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Treatment and study plan

nasal Desmopressin

Drug

compare the effect of nasal desmopressin versus oral bisoprolol for controlling bleeding and improving surgical field clarity during functional endoscopic sinus surgery.

Other names: oral Bisoprolol

Primary outcomes

  1. the volume of blood loss in cubic centimeter

    Time frame: during surgeries

    the volume of blood loss in cubic centimeter calculating as (the volume of fluid in the suction bottle after deduction of normal saline volume that will be used for endoscopic scrub, plus the volume of soaked cotton strip (fully soaked will be estimated to contain 5 ml of blood and a partially soaked will be estimated to contain 2.5 ml)

Secondary outcomes

  1. The quality of surgical field

    Time frame: measured every 15 minutes from beginning of surgery until the end of surgery

    The quality of surgical field using Boezaart surgical field grading scale

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Preoperative Nasal Desmopressin Versus Oral Bisoprolol for Controlling Bleeding and Improving Surgical Field During Unilateral Functional Endoscopic Sinus Surgery

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 24, 2022
Registry last updated
Nov 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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