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

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

Study Overview

• Status: Completed
• Conditions: Bleeding
• Intervention / Treatment: Drug: nasal Desmopressin

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Sharqia
    • Zagazig, Sharqia, Egypt
      • Heba M Fathi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Desmopressin group (Group D); patients will received single puff (10 μg) of nasal desmopressin in the nasal cavity at the side of surgery 30 min preoperative.	Drug: nasal Desmopressin; 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
Active Comparator: Bisoprolol group (group B); patients will receive Oral bisoprolol 2.5 mg (Concor 2.5 mg; Merck/Amoun) 90 min preoperative.	Drug: nasal Desmopressin; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the volume of blood loss in cubic centimeter	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)	during surgeries

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The quality of surgical field	The quality of surgical field using Boezaart surgical field grading scale	measured every 15 minutes from beginning of surgery until the end of surgery

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Heba M Fathi, Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): November 5, 2022

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: June 17, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 5, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Desmopressin ,bisoprolol,Sinus Surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Natriuretic Agents; Hemostatics; Coagulants; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Antidiuretic Agents; Bisoprolol; Deamino Arginine Vasopressin
• Other Study ID Numbers: 9262

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No