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.
Nasal Desmopressin Versus Topical Epinephrine in Endonasal Dacryocystorhinostomy
Status
Completed
Phase
Not applicable
Enrollment
52
Locations
1
Results
Not posted
Publications
6
Study summary
What the protocol is testing.
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.
Full 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
Treatment arms and agents.
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.
Timeline
From registration to results.
First posted
Aug 19, 2022
Study start
Sep 1, 2022
Primary completion
Jun 1, 2023
Study completion
Jun 1, 2023
Results posted
Not reported
Registry updated
Oct 1, 2024
Outcomes
What the study measures.
Primary outcomes
Intraoperative blood loss
Time frame · Measurement 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.
Intraoperative blood loss
Time frame · 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 outcomes
The Surgical field clarity
Time frame · 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 in heart rate (HR) in beat per minute
Time frame · 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.
Change mean arterial blood pressure (MAP) in mmHg
Time frame · 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)
Time frame · 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.
Change in serum sodium level
Time frame · preoperative and after 12 hours postoperative
Serum sodium level will be measured pre \& postoperative to detect and manage any sodium disturbances.
The surgeon's satisfaction
Time frame · 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).
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Sex
- ALL
- 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.
Study locations
1 registered sites.
Egypt. Showing up to 24 locations stored in the fast local snapshot.
Zagazig university hospital
Zagazig, Al-Sharkia, Egypt
Publications
Results and literature.
PMID 34318721 ↗Vinciguerra A, Nonis A, Giordano Resti A, Ali MJ, Bussi M, Trimarchi M. Role of anaesthesia in endoscopic and external dacryocystorhinostomy: A meta-analysis of 3282 cases. Eur J Ophthalmol. 2022 Jan;32(1):66-74. doi: 10.1177/11206721211035616. Epub 2021 Jul 28.PMID 25895497 ↗Shao H, Kuang LT, Hou WJ, Zhang T. Effect of desmopressin administration on intraoperative blood loss and quality of the surgical field during functional endoscopic sinus surgery: a randomized, clinical trial. BMC Anesthesiol. 2015 Apr 17;15:53. doi: 10.1186/s12871-015-0034-8.PMID 31161361 ↗Jahanshahi J, Tayebi E, Hashemian F, Bakhshaei MH, Ahmadi MS, Seif Rabiei MA. Effect of local desmopressin administration on intraoperative blood loss and quality of the surgical field during functional endoscopic sinus surgery in patients with chronic rhinosinusitis: a triple-blinded clinical trial. Eur Arch Otorhinolaryngol. 2019 Jul;276(7):1995-1999. doi: 10.1007/s00405-019-05435-3. Epub 2019 Jun 3.PMID 25919247 ↗Gruber RP, Zeidler KR, Berkowitz RL. Desmopressin as a hemostatic agent to provide a dry intraoperative field in rhinoplasty. Plast Reconstr Surg. 2015 May;135(5):1337-1340. doi: 10.1097/PRS.0000000000001158.PMID 26152362 ↗Korkmaz H, Yao WC, Korkmaz M, Bleier BS. Safety and efficacy of concentrated topical epinephrine use in endoscopic endonasal surgery. Int Forum Allergy Rhinol. 2015 Dec;5(12):1118-23. doi: 10.1002/alr.21590. Epub 2015 Jul 8.PMID 7614641 ↗Boezaart AP, van der Merwe J, Coetzee A. Comparison of sodium nitroprusside- and esmolol-induced controlled hypotension for functional endoscopic sinus surgery. Can J Anaesth. 1995 May;42(5 Pt 1):373-6. doi: 10.1007/BF03015479.
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