Nasal Desmopressin Versus Topical Epinephrine in Endonasal Dacryocystorhinostomy
- Conditions
- Anesthesia
- Interventions
- Registration Number
- NCT05507476
- Lead Sponsor
- Zagazig University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Desmopressin group 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 "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.
- Primary Outcome Measures
Name Time Method Intraoperative blood loss Measurement will be done at 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.
- Secondary Outcome Measures
Name Time Method Change in serum sodium level preoperative and after 12 hours postoperative Serum sodium level will be measured pre \& postoperative to detect and manage any sodium disturbances.
Change in heart rate (HR) in beat per minute will 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.
The surgeon's satisfaction At the end of surgery The surgeon was asked to rate satisfaction at the end of surgery (4 =excellent, 3 = good, 2 = fair, 1 = poor, 0 = extremely poor).
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)
Change mean arterial blood pressure (MAP) in mmHg 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) from baseline.
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.
Trial Locations
- Locations (1)
Zagazig university hospital
🇪🇬Zagazig, Al-Sharkia, Egypt