Nasal Desmopressin Versus Topical Epinephrine in Endonasal Dacryocystorhinostomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Desmopressin Acetate Nasal, 10 μg/0.1 ml per spray
* Drug: Epinephrine topical 1:100,000 Nasal Packs


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Desmopressin group<br>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<br>* 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.<br>* Other names: Minirin 10 μg/0.1 ml per spray;|
| Active Comparator: Epinephrine group<br>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<br>* 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.<br>* Other names: Adrenaline 1 mg / 1ml;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative blood loss | 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. | Measurement will be done at the 30th minutes of the start of surgery. | 
| Intraoperative blood loss | 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. | Measurement will be done at 60th minutes of the start of surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Surgical field clarity | 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) | at the end of surgery | 
| Change in heart rate (HR) in beat per minute | Change in heart rate (HR) from baseline. | will 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) in mmHg | Change mean arterial blood pressure (MAP) from baseline. | will be recorded at 2 minutes, 5 minutes, 10 minutes, 30 minutes and 60 minutes after topical epinephrine packs insertion. | 
| Change oxygen saturation (SPO2) | Change oxygen saturation (SPO2) from baseline. | will be recorded at 2 minutes, 5 minutes, 10 minutes, 30 minutes and 60 minutes after topical epinephrine packs insertion. | 
| Change in serum sodium level | Serum sodium level will be measured pre & postoperative to detect and manage any sodium disturbances. | preoperative and after 12 hours postoperative | 
| The surgeon's satisfaction | The surgeon was asked to rate satisfaction at the end of surgery (4 =excellent, 3 = good, 2 = fair, 1 = poor, 0 = extremely poor). | At the end of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Desmopressin, Dacryocystorhinostomy