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

NCT05430048 | Completed Phase 2

• 1 other identifier: 9262
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Bleeding

Keywords

Desmopressin ,bisoprolol,Sinus Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The quality of surgical field

  measured every 15 minutes from beginning of surgery until the end of surgery

Study Arms (2)

Desmopressin group (Group D)

ACTIVE COMPARATOR

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

Bisoprolol group (group B)

ACTIVE COMPARATOR

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

Drug: nasal Desmopressin

Interventions

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.

Also known as: oral Bisoprolol

Bisoprolol group (group B); Desmopressin group (Group D)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Heba M Fathi

Zagazig, Sharqia Province, Egypt

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Bisoprolol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Heba M Fathi

  Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Heba M Fathi

Model Details: comparing Preoperative Nasal Desmopressin versus Oral Bisoprolol for Controlling Bleeding and Improving Surgical Field during Unilateral Functional Endoscopic Sinus Surgery

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 24, 2022
• Study Start: July 1, 2022
• Primary Completion: October 30, 2022
• Study Completion: November 5, 2022
• Last Updated: November 10, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)