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Nasal Desmopressin Versus Topical Epinephrine in Endonasal Dacryocystorhinostomy

Effects of Nasal Desmopressin Spray Versus Topical Epinephrine on Surgical Field Clarity and Hemodynamics in Endonasal Dacryocystorhinostomy: a Randomized Clinical Study.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05507476
Enrollment
52
Registered
2022-08-19
Start date
2022-09-01
Completion date
2023-06-01
Last updated
2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Desmopressin, Dacryocystorhinostomy

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.

Detailed description

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.

Interventions

DRUGDesmopressin 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.

DRUGEpinephrine 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.

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative blood lossMeasurement will be done at the 30th minutes of the start of surgery.Estimation of intraoperative blood loss will be done at 30th minutes of surgery. by calculating the loss of blood and irrigation saline in 50 mL-graded suction canisters.

Secondary

MeasureTime frameDescription
Change in heart rate (HR) in beat per minutewill be recorded at 2 minutes, 5 minutes, 10 minutes, 30 minutes and 60 minutes after topical epinephrine packs insertion.Change in heart rate (HR) from baseline.
Change mean arterial blood pressure (MAP) in mmHgwill be recorded at 2 minutes, 5 minutes, 10 minutes, 30 minutes and 60 minutes after topical epinephrine packs insertion.Change mean arterial blood pressure (MAP) from baseline.
The Surgical field clarityat the end of surgeryThe 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)
Change in serum sodium levelpreoperative and after 12 hours postoperativeSerum sodium level will be measured pre & postoperative to detect and manage any sodium disturbances.
The surgeon's satisfactionAt the end of surgeryThe surgeon was asked to rate satisfaction at the end of surgery (4 =excellent, 3 = good, 2 = fair, 1 = poor, 0 = extremely poor).
Change oxygen saturation (SPO2)will be recorded at 2 minutes, 5 minutes, 10 minutes, 30 minutes and 60 minutes after topical epinephrine packs insertion.Change oxygen saturation (SPO2) from baseline.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026