Nasal Desmopressin Versus Topical Epinephrine in Endonasal Dacryocystorhinostomy

Sponsor
Zagazig University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05507476
Collaborator
(none)
48
2
5

Study Details

Study Description

Brief Summary

Dacryocystorhinostomy aims to create a channel between the lacrimal sac and nasal mucosa to relieve nasolacrimal duct occlusion. General anesthesia is still preferred by many surgeons to secure the airway and control blood pressure. Bleeding even minor can obscure the surgical field. This can extend the operative time & increase the failure rate. The hemostatic effect of desmopressin on the quality of the surgical field was investigated in patients undergoing endoscopic sinus surgery and revealed that desmopressin could reduce intraoperative bleeding.

Condition or Disease Intervention/Treatment Phase
  • Drug: Desmopressin Acetate Nasal, 10 μg/0.1 ml per spray
  • Drug: Epinephrine topical 1:100,000 Nasal Packs
N/A

Detailed Description

Dacryocystorhinostomy aims to create a channel between the lacrimal sac and nasal mucosa to relieve nasolacrimal duct occlusion. General anesthesia is still preferred by many surgeons to secure the airway and control blood pressure. Bleeding even minor can obscure the surgical field. This can extend the operative time & increase the failure rate. The surgical field can be optimized by several techniques such as controlled hypotension, and local vasoconstrictors application, however, none of them can stand alone as a perfect choice for a bloodless surgical field. The hemostatic effect of intranasal desmopressin on the quality of the surgical field was investigated in patients undergoing endoscopic sinus surgery and revealed that desmopressin could reduce intraoperative bleeding. Hemostatic effects of desmopressin can be attributed to the rising in plasma levels of von Willebrand factor, coagulation factor VII and tissue plasminogen activator. Desmopressin also can play a role in improving platelet adhesiveness and stability of vascular endothelium. The topical application of 1:100,000 epinephrine is a common practice for intranasal surgical procedures. It decreases blood loss and improves endoscopic visualization. Up till now, no study compares nasal desmopressin and topical epinephrine effects on surgical field clarity and hemodynamics.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Nasal Desmopressin Spray Versus Topical Epinephrine on Surgical Field Clarity and Hemodynamics in Endonasal Dacryocystorhinostomy: A Randomized Clinical Study.
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Desmopressin group

The patient will receive two puffs of desmopressin acetate 10 µg/puff in the side of the nasal cavity ipsilateral to the obstructed lacrimal duct (20 μg totally) 60 minutes before surgery "Minirin 10 μg/0.1 ml per spray, Ferring Pharmaceutical Company". Three normal saline-soaked packs will be placed in the middle meatus for 5 minutes immediately before the start of surgery.

Drug: Desmopressin Acetate Nasal, 10 μg/0.1 ml per spray
The patient will receive two puffs of desmopressin acetate 10 µg/puff in the side of the nasal cavity ipsilateral to the obstructed lacrimal duct (20 μg totally) 60 minutes before surgery.
Other Names:
  • Minirin 10 μg/0.1 ml per spray
  • Active Comparator: Epinephrine group

    The patient will receive topical 1:100,000 epinephrine in the side of the nasal cavity ipsilateral to the obstructed lacrimal duct via 3 soaked packs placed in the middle meatus for 5 minutes immediately before the start of surgery. The patient will also receive two puffs of normal saline "prepared in emptied Minirin bottle" in the same nasal cavity 60 minutes before surgery.

    Drug: Epinephrine topical 1:100,000 Nasal Packs
    The patient will receive topical 1:100,000 epinephrine in the side of the nasal cavity ipsilateral to the obstructed lacrimal gland via 3 soaked packs placed in the middle meatus for 5 minutes immediately before the start of surgery.
    Other Names:
  • Adrenaline 1 mg / 1ml
  • Outcome Measures

    Primary Outcome Measures

    1. Intraoperative blood loss [Measurement will be done at the 60th minutes of the start of surgery.]

      Estimation of intraoperative blood loss will be done at 60th minutes of surgery by calculating the loss of blood and irrigation saline in 50 mL-graded suction canisters.

    2. The Surgical field clarity [at the end of surgery]

      The quality of surgical field based on BOEZAART grading system(0 no bleeding; 1 slight bleeding: no suctioning is needed; 2 slight bleeding: occasional suctioning needed;, 3 sight bleeding: frequent suctioning required, bleeding threatens surgical field a few seconds after suction is removed; 4 moderate bleeding: frequent suctioning required and bleeding threatens surgical field directly after suction is removed; 5 severe bleeding: constant suctioning required)

    3. Change in Intraoperative hemodynamics [will be recorded at 10-min intervals for the first 2 hours of the start of surgery.]

      Change in heart rate (HR), mean arterial blood pressure (MAP) and oxygen saturation (SaO2) from baseline.

    4. Change in serum sodium level [Serum sodium level will be measured preoperative, 12 hours and 24 hours postoperative.]

      Serum sodium level will be measured pre & postoperative to detect and manage any sodium disturbances.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age: 18-45 years old.

    • Physical status: ASA I & II.

    • Type of operations: elective endonasal dacryocystorhinostomy under general anesthesia.

    • Written informed consent from the patient.

    Exclusion Criteria:
    • Patient refusal.

    • Known hypersensitivity to study drugs.

    • Nasal pathology as active infection or an anatomical abnormality.

    • Hyponatremia "serum Na+ less than 135".

    • Coagulation disorders.

    • Renal or cardiovascular disorders.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Zagazig University

    Investigators

    • Principal Investigator: Alshaimaa Abdel Fattah Kamel, MD, Assistant professor of Anesthesia, Intensive Care & Pain management,Zagazig University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mohamed Gaber, MD, Lecturer of Anesthesia, Intensive Care & Pain management,Zagazig University, Zagazig University
    ClinicalTrials.gov Identifier:
    NCT05507476
    Other Study ID Numbers:
    • Nasal Desmopressin in DCR
    First Posted:
    Aug 19, 2022
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mohamed Gaber, MD, Lecturer of Anesthesia, Intensive Care & Pain management,Zagazig University, Zagazig University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 19, 2022