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

Primary Purpose

Bleeding

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
nasal Desmopressin
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bleeding focused on measuring Desmopressin ,bisoprolol,Sinus Surgery

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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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Sites / Locations

  • Heba M Fathi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Desmopressin group (Group D)

Bisoprolol group (group B)

Arm Description

patients will received single puff (10 μg) of nasal desmopressin in the nasal cavity at the side of surgery 30 min preoperative.

patients will receive Oral bisoprolol 2.5 mg (Concor 2.5 mg; Merck/Amoun) 90 min preoperative.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

The quality of surgical field
The quality of surgical field using Boezaart surgical field grading scale

Full Information

First Posted
June 17, 2022
Last Updated
November 5, 2022
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT05430048
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
November 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding
Keywords
Desmopressin ,bisoprolol,Sinus Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
comparing Preoperative Nasal Desmopressin versus Oral Bisoprolol for Controlling Bleeding and Improving Surgical Field during Unilateral Functional Endoscopic Sinus Surgery
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
double blinded
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Desmopressin group (Group D)
Arm Type
Active Comparator
Arm Description
patients will received single puff (10 μg) of nasal desmopressin in the nasal cavity at the side of surgery 30 min preoperative.
Arm Title
Bisoprolol group (group B)
Arm Type
Active Comparator
Arm Description
patients will receive Oral bisoprolol 2.5 mg (Concor 2.5 mg; Merck/Amoun) 90 min preoperative.
Intervention Type
Drug
Intervention Name(s)
nasal Desmopressin
Other Intervention Name(s)
oral Bisoprolol
Intervention Description
compare the effect of nasal desmopressin versus oral bisoprolol for controlling bleeding and improving surgical field clarity during functional endoscopic sinus surgery.
Primary Outcome Measure Information:
Title
the volume of blood loss in cubic centimeter
Description
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)
Time Frame
during surgeries
Secondary Outcome Measure Information:
Title
The quality of surgical field
Description
The quality of surgical field using Boezaart surgical field grading scale
Time Frame
measured every 15 minutes from beginning of surgery until the end of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heba M Fathi
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heba M Fathi
City
Zagazig
State/Province
Sharqia
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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