Clinical trial NCT05430048: Nasal Desmopressin Versus Oral Bisoprolol for Controlling Bleeding During Endoscopic Sinus Surgery
Official title: Preoperative Nasal Desmopressin Versus Oral Bisoprolol for Controlling Bleeding and Improving Surgical Field During Unilateral Functional Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bleeding
Keywords: Desmopressin ,bisoprolol,Sinus Surgery
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-06-24
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comparing Preoperative Nasal Desmopressin versus Oral Bisoprolol for Controlling Bleeding and Improving Surgical Field during Unilateral Functional Endoscopic Sinus Surgery
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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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Primary outcomes:
measure: the volume of blood loss in cubic centimeter
timeFrame: during surgeries
Secondary outcomes:
measure: The quality of surgical field
timeFrame: measured every 15 minutes from beginning of surgery until the end of surgery
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Heba M Fathi
state: Sharqia
Study officials:
affiliation: Zagazig University
name: Heba M Fathi
role: PRINCIPAL_INVESTIGATOR
References: